Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed.
Worldwide distribution: US states: AZ, FL, IL, LA, MA, NJ, OR, SC, and TX. Armenia, Austria, Belgium, Colombia, Czech Republic, France, Hungary, Iran, Israel, India, Italy, Kuwait, Latvia, Lebanon, Luxembourg, Mexico, Morocco, Poland, Portugal, Russia, Saudi Arabia, South Africa, Spain, Switzerland, and United Arab Emirates.
Cordis EMPIRA RX PTCA Dilatation Catheter Catalog # 85R30300S  For cardiovascular use.
Dilatation catheters could exhibit radial versus axial tears should they burst during inflation.
Worldwide Distribution: US (nationwide) and country of: Canada.
Philips IntellVue Info Center iX 866023; PIIC iX Upgrade 866024; IntellVue Server iX Upgrade 866026; PIIC Classic Upgrade 866117  Patient Physiological Monitor.
If a customer creates customized trend scales in the trend review tile and the iX or primary server reboots for any reason, the iX(s) will enter a reboot loop.  If one iX reboots, the issue will impact only those patients monitored on that device.  If the primary server reboots, all patients across all iX devices will be impacted.
BARF World Brand Juicy Chicken Recipe 12 patties packed into a 6 lb bag.    UPC 3752800101    Distributed by:  BARF World Inc.  3840 Blackhawk Road, Suite 100  Danville, CA 94506
11 cases lot S220, 58 cases lot T220. 24 lb cases contains 4 x 6 lb bags.
Product was manufactured on the same equipment as product that tested positive for Salmonella by the Minnesota Dept of Public Health.
BARF World Brand Juicy Lamb Recipe 12 patties packed into a 6 lb bag.    UPC 3752800104    Distributed by:  BARF World, Inc.  3840 Blackhawk Road, Suite 100  Danville, CA 94506
14 cases (24 lb case contains 4 x 6 lb bags)
BARF World Brand Juicy Combination Recipe 12  patties packed into a 6 lb bag.    UPC 3752800106    Distributed by:  BARF World, Inc.  3840 Blackhawk Road, Suite 100  Danville, CA 94506
9 cases, 24 lb. case contains 4 x 6 lb bags.
BARF World Brand Variety Pack; 12 patties packed into a 6 lb bag- one each of Chicken, Beef, Lamb, Combination.  No UPC - contains individual UPC for each variety.    Distributed by:  BARF World, Inc.  3840 Blackhawk Road, Suite 100  Danville, CA 94506
200 cases (24 lb case contains 4 x 6 lb bags.)
Worldwide Distribution -- USA, including the states of AZ, IL, MA, MO, NC, OR, TX, VA, and WI; and, the countries of Australia, Austria, Chile, China, Colombia, Czech Republic, Greece, Israel,  Italy, Japan, Malaysia, Netherlands, Norway, Oman, Saudi Arabia, South Korea, Spain, Sweden, Switzerland, and United Kingdom.
Leica Ceiling Mount MSF-1 for use with M841 and M501 operating microscopes.  Article Number 10446781 utilizes a supply voltage of 230 V. Article Number 10446782 utilizes a supply voltage of 110 V.   Intended to be used for improving the visibility of objects through magnification and illumination.
Leica Ceiling Mount MSF-1; Article Numbers: 10446781, 10446782
The ceiling mount supplier encountered an event in which the drive screw in the motor unit, which lifts and lowers the lower lift arm, broke. As a result, the lift arm fell down approx. 60 cm (23.6 inches).
Leica Ceiling Mount MS-1F & MC-1F for use with the M500 N operating microscope. Article Number 10446657 utilizes a supply voltage of 110 V. Article Number 10446658 utilizes a supply voltage of 220 V.   Intended to be used for improving the visibility of objects through magnification and illumination.
Leica Ceiling Mounts MS-1F, MC-1F; Article Numbers: 10446657, 10446658
Bailey's Choice 100% Chicken Treat, Net wt. 5oz, Made in Waleska, GA .
Bailey's Choice 100% Chicken Breast Treat, Made in Waleska, GA
Bailey's Choice 100% Teriyaki Chicken Treat, Made in Waleska, GA
vitaliKOR Ready When You Are, Fast Acting Formula Dietary Supplement capsules, 40 count bottle, Distributed by Vitality Research Labs, LLC, Las Vegas, NV 89148.
11,523 bottles of lot K58Q; 54,255 bottles of lot F50Q
Marketed Without an Approved NDA/ANDA: FDA sampling found undeclared  vardenafil and tadalafil in vitaliKOR capsules
REDUCE WEIGHT FRUTA PLANTA Capsules, 400 mg, supplied in 30 count boxes, distributed by MyNicKnaxs, LLC., Deltona, FL
Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredient: Phenolphthalein.
JIANFEIJINDAN Activity Girl Capsules, 400 mg, supplied in 30 count boxes, distributed by MyNicKnaxs, LLC, Deltona, FL
Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared ingredient: N-di-desmethylsibutramine, an analog of sibutramine
Fruta BIO 400 mg capsules, supplied in 30 count boxes, distributed by MyNicKnaxs, LLC, Deltona, FL
Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredients: Sibutramine and Phenolphthalein .
Super Fat Burning Bomb Capsules, 400 mg, supplied in 30 count boxes, distributed by MyNicKnaxs, LLC, Deltona, FL
Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredients: Phenolphthalein and N-desmethylsibutramine
Pill for weight reduction, (Japanese Chinese Formula from Japan Hokkaido Cangye Pharmacy Co, Ltd) 400 mg, supplied in 40 count boxes, distributed by MyNicKnaxs, LLC, Deltona, FL
Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredient: Phenolphthalein
SlimEasy Herbs Capsule, 400 mg, supplied in 30 count boxes, distributed by MyNicKnaxs, LLC, Deltona, FL
Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredient: sibutramine and N-desmethylsibutramine
Meizi Evolution Soft Gel Capsules, supplied in 30 count bottles, distributed by MyNicKnaxs, LLC, Deltona, FL
Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredient: N-desmethylsibutramine, benzylsibutramine, and sibutramine
Slim Xtreme Weight loss capsules, 500 mg, supplied in 30 count bottles, Another product from Globe All Wellness, LLC Hollywood, FL 33020, distributed by MyNicKnaxs, LLC Deltona, FL
Magic Slim capsules, supplied in 60 count bottles, distributed by MyNicKnaxs, LLC, Deltona, FL
Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredients: N-desmethylsibutramine, benzylsibutramine, and sibutramine
Meizitang Strong Version Botanical Slimming, Soft Gel Capsules, 650 mg, supplied in 30 count bottles, distributed by MyNicKnaxs, LLC, Deltona, FL
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Venlafaxine HCl Extended-Release Capsules, 150 mg, 90-count Unit of Use bottles, Rx only, Distributed by: Greenstone LLC, Peapack, NJ  07977, NDC 59762-0182-2, UPC 3 59762-0182-2 9.
Presence of Foreign Tablets/Capsules: A Pharmacist reported a foreign capsule with markings (TKN 250) and identified as a Tikosyn (dofetilide) capsule in a lot of Effexor XR 150 mg capsules that was packaged in the same packaging campaign as this Venlafaxine HCl lot.
Harry & David; WILD 'N SPICY; DOS QUESOS DIP; NET WT 1 lb.; (453g);Mild; in glass jars; MADE FOR HARRY AND DAVID, MEDFORD OR, HARRYANDDAVID.COM; 800-547-3033
2712 units (units are glass jars;  cases contain 12 jars each for a total of  226 cases shipped.)
Undeclared Wheat due to a supplier's inadvertent use of a wheat product instead of whey in preparing the cheese pre-mix for the recalling firm.
Harry & David; WILD 'N SPICY; JALAPENO TOMATO CHEESE DIP; NET WT 1 lb.; (453g);Medium;  in glass jars; MADE FOR HARRY AND DAVID, MEDFORD, OR, HARRYANDDAVID.COM; 800-547-3033
636 units (units are glass jars;  cases contain 12 jars each for a total of  53 cases shipped.)
Undeclared Wheat due to a supplier's inadvertent use of a wheat product instead of whey in preparing the cheese premix for the recalling firm.
Bella Vi INSANE Bee Pollen Dietary Supplement Capsules, 60 count bottles, www.BellaViProducts.com, distributed by Pure Edge Nutrition, LLC, Toms River, NJ
Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein
Bella Vi BTrim MAX Dietary Supplement capsules, 60 count bottles, www.BellaViProducts.com, distributed by Pure Edge Nutrition, LLC, Toms River, NJ
Bella Vi BTrim ULTIMATE BOOST Dietary Supplement capsules, 30 count bottles, www.BellaViProducts.com, distributed by Pure Edge Nutrition, LLC, Toms River, NJ
Bella Vi eXtreme ACCELERATOR Dietary Supplement Capsules, 30 count bottles, www.BellaViProducts.com, distributed by Pure Edge Nutrition, LLC, Toms River, NJ
Bella Vi INSANE AMP'D Dietary Supplement capsules, 60 count bottles, www.BellaViProducts.com, distributed by Pure Edge Nutrition, LLC, Toms River, NJ
Bella Vi AMP'D UP Advanced Weight Loss Dietary Supplement capsules, 60 count bottles, www.BellaViProducts.com, distributed by Pure Edge Nutrition, LLC, Toms River, NJ
Midazolam 0.2 mg/2 mL 0.9% Sodium Chloride syringes, Total dosage: 0.4 mg per 2 mL, Rx Only, Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd, Noblesville, Indiana, NDC 45183-0014-69.
Superpotent Drug: Product contains twice the stated amount of midazolam.
Blood product, which was labeled as leukoreduced, but failed the post filtration acceptance criteria for white blood cell count, was distributed.
Pantoprazole Sodium, Delayed-release tablets, USP, 40 mg tablets, 100 (10x10) unit dose packages, Manufactured by Dr. Reddy's Laboratories Limited, India and Distributed by Major Pharmaceuticals, Livonia, MI --- NDC 0904-6235-61
No lot or expiration date is displayed on this carton.
Correct Labeled Product Miscart/Mispack: some cartons labeled as Pantoprazole Sodium Delayed-Release may contain correctly labeled blister cards of Lorazepam tablets
US distribution in the state of North Carolina.
Portex Low Dead Space Connector with Sideport, 3.5mm   Product Usage:  The connector is used to attach the endotracheal tube to the patient breathing circuit. The low dead space connector minimizes mechanical dead space and subsequent carbon dioxide rebreathing. The connector's sideport permits access for administration of artificial surfactant, airway pressure monitoring, gas sampling, and instillation of sterile saline for airway leakage.
One lot of 3.0mm sized Connectors, Product Reorder No. 10035-05PS, Lot No. 2553426 were placed in packages labeled as size 3.5mm.
Worldwide Distribution: US Nationwide and the country of Canada.
''bluephase style Light probe Pin-point 6>2 mm black***REF # 636 241''.   Ultraviolet activator for polymerization for use during dental curing.
Subject of this recall is an accessory to a dental curing light called Bluephase Style. The accessory is a pin point light probe. A stock check revealed broken glass fibers between the connector and the fiber bundle in a large number of these light probes.
El Original pa' ya To Go by hot pandeyuca brand  Soft Bread Pan Alinado
During an FDA inspection, it was discovered that the label of several products failed to declare the components ingredients of a butter flavor that included allergens FD&C Yellow #5, FD&C Yellow #6 and FD&C Red #40.
El Original pa' ya To Go by hot pandeyuca brand  Cheese Bread Pan de Queso Grande
El Original pa' ya To Go by hot pandeyuca brand  Small Cheese Bread Quesipan
CUBICIN (daptomycin for injection), 500 mg single-use vial, Rx only, Manufactured for: Cubist Pharmaceuticals, Inc., Lexington, MA  02421, NDC 67919-011-01, UPC 3 67919-011-01 6.
Presence of Particulate Matter: Customer complaint stating that one vial contained a glass shard.
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Red Blood Cells Leukocytes Reduced Irradiated
Worldwide Distribution: US Distribution to states of: IL, OH and TN; and country of: Italy.
Siemens Healthcare Diagnostics Vista Air Compressor    Siemens Healthcare Diagnostics Dimension Vista System is an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids. Dimension Vista chemical and immunochemical applications use photometric, turbidimetric, chemiluminescence, nephelometric and integrated ion-selective multisensory technology for clinical use.
Product Siemens Material Number (SMN) Dimension Vista 500 Domestic: 10284473  International: 10488224  Dimension Vista 1500 Domestic: 10444801  International: 10444802
Siemens Healthcare Diagnostics is recalling the Vista Air Compressor replacement part: SMN 10706557 Desc: SKIT Air Compressor Assy,used on the Dimension Vista 500 and Dimension Vista 1500 systems because a small  number of Vista Air Compressors were miswired, which if  installed and powered up, could cause a fire, or become  an electrical shock hazard.
Tissue-Tek PARAFORM PROC/EMB/MEDIUM, FORMULA 3 - 8x1Kg.
Sakura Finetek USA, Inc. is conducting a voluntary field corrective action for Tissue-TEK Paraform Processing/embedding Medium Formula3 Paraffin because it was identified that the affected lot has variations in melting temperature.
Red Blood Cells (Apheresis) Leukocytes Reduced
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
US Distribution including the states of CA, CT, FL, GA, NY, SD and TX.
Synthes Matrix Mandible Short Cut Plate Cutter    Synthes Matrix Mandible Short Cut Plate Cutter is intended for oral, maxillofacial surgery.
part number: 03.503.057, lot number 8453237
It was discovered internally that the face of the Synthes Matrix Mandible Short Cut Plate Cutter has the potential for discoloration/corroded material in the affected lot.
United Bakery Grissini Parmesan Bread Sticks,; Made with Extra Virgin Olive Oil and Grano Padano Cheese;  All Natural, Trans Fat Free;  Packaged in 8 oz  (227g) and 4.5 oz  (128g) containers.  Also packaged for Safeway - Safeway Select Parmesan Grissini Breadsticks, 8 oz. (227g) containers.  Made in USA  Ingredient: Wheat Flour, Water, Unsalted butter, yeast, Extra virgin Olive Oil, Imported Grano Padano Cheese, garlic, sea salt, malted barley, non fat milk, ascorbic acid, natural enzymes.  United Bakery, W. Sacramento, CA
14, 356 cases - sold in 18 pack cases and 12 pack cases
Internal label review found egg is an ingredient of Grano Padano Cheese used in Parmesan Bread Sticks, but not declared in product ingredient statement or allergen statement.
NaturaLyte Liquid Bicarbonate Concentrate, 6.4 liter bottle to be used with a hemodialysis unit; Part Number: 08-4000-LB.    The concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates.
Container cap may contain foreign material- 0.60% - 0.80% Manganese
Maquet PowerLED 700.    Product Usage;  To provide illumination to the surgical area or the patient.
Maquet has identified an issue with the Maquet PowerLED 700 (certain serial numbers).  One or several plastic fixation tabs can break, which can cause the ambient light module to partially detach.
Product was sold to 2 distributors in Washington State.
Raw, frozen, vacuum-packaged rock fish (portions, fillets, and whole fish, various sizes).
T. H. Seafood, Inc., is recalling raw, frozen, vacuum packed rockfish due to labeling instructions that do not direct the consumer to ''Keep Frozen-Thaw Under Refrigeration'' to control  the hazard of Clostridium botulinum.
Raw, frozen, vacuum-packaged black cod (portions, fillets, and whole fish, various sizes).
T. H. Seafood, Inc., is recalling raw, frozen, vacuum packed black cod due to  labeling instructions that do not direct the consumer to ''Keep Frozen-Thaw Under Refrigeration'' to control  the hazard of Clostridium botulinum.
Raw, frozen, vacuum-packaged halibut (portions, fillets, and whole fish of various sizes).
T. H. Seafood, Inc., is recalling raw, frozen, vacuum packed  halibut due to labeling instructions that do not direct the consumer to ''Keep Frozen-Thaw Under Refrigeration'' to control  the hazard of Clostridium botulinum.
Raw, frozen, vacuum-packaged salmon (portions, fillets, and whole fish, various sizes).
T. H. Seafood, Inc., is recalling raw, frozen, vacuum packed salmon due to labeling instructions that do not direct the consumer to ''Keep Frozen-Thaw Under Refrigeration'' to control  the hazard of Clostridium botulinum.
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
Blood product, for which documentation of the donor history was incomplete, was distributed.
Blood and Blood Products for Reprocessing
Blood product, for which the documentation of the donor history was incomplete, was distributed.
Alere Triage D-Dimer Test PN 98100, Lot W53884B.  The Alere Triage D-Dimer Test is a fluorescence immunoassay to be used with the Alere Triage Meters for the quantitative determination of cross-linked fibrin degradation products containing D-dimer in EDTA anticoagulated whole blood and plasma specimens.  .  The Alere Triage D-Dimer test is intended for use as an aid in the assessment and evaluation of patients suspected of having disseminated intravascular coagulation or thromboembolic events including pulmonary embolism.
Alere initiated this recall because a limited number of Alere Triage D-Dimer devices from PN 98100 Lot W53884B were incorrectly manufactured.  As a result, when testing patient sample these affected devices will either generate an error code (e.g. E4 error), or they may generate an incorrect result.
HLD Systems Model 610 Washer/High Level Disinfector.     Maximum weight of the Model 610 when filled with water is approximately 450 pounds. The dimensions of the system are: Width: 26.5'' (67 cm); Depth: 33'' (83 cm); Height: 46.5'' (118 cm) to top of control panel; 64'' (162.6 cm)- height clearance with lid open.    Product Usage:  Usage:  This device washes reusable medical devices and disinfects them with high temperature hot water (pasteurization). The devices are washed with a cleaning solution (containing NaClO (sodium hypochlorite), surfactants, and detergents) to aid in the removal of debris and visible stains. Next, the medical devices and rinsed two times with water. The final, disinfection step uses only hot water at 160 F  2 F for 30 minutes.
Cenorin LLC is voluntarily recalling HLD Systems Model 610 Washer/High Level Disinfector due to a potential risk of the system not injecting the proper amount of cleaning fluid during the wash cycle and not achieving the desired level of debris reduction.
Worldwide Distribution -- USA, including CA, and country of: GERMANY.
Armstrong Grommet with wire Otological Ventilation Tube Catalog #:  VT-0507-01, Sterilized by Ethylene Oxide, Rx Only.    Intended to provide ventilation to the middle ear space through the tympanic membrane.
One lot of ventilation tubes have mixed tubes with wire attached to the slanted flange and ventilation tubes with wire attached to the straight flange.  This poses no health hazard to the user or patient.
Worldwide Distribution - US including the states of Arizona, Delaware, Ohio, Tennessee, and North Carolina; and the countries of Mexico, England and Italy.
enGen (TM) Laboratory Automation System Configured with TCAutomation'' Software v3.5 -- For in vitro quantitative measurement of a variety of analytes of clinical interest ---   The VITROS 5,1 FS Chemistry System with enGenTM Laboratory Automation System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods.). ---The enGen (TM) Lab Automation System is a modification to VITROS Analyzers that includes the addition of an automated track sub-system (TCAutomation) for pre-analytical and post-analytical sample and data management. In addition to an Automated Track Sub-system, the enGen (TM) System includes one or more VITROS Chemistry, Immunodiagnostic and/or Integrated Systems (clinical analyzers) as well as a Data Management Subsystem (Middleware), and a Software Configuration (gsb) File. The enGen System is typically interfaced with a Laboratory Information System (LIS) via connectivity facilitated at the Data Management Subsystem level. By using the enGen (TM) Laboratory Automation System as a communication interface between the LIS and the clinical analyzers in the laboratory, the user can manage the workflow to the analyzers and other devices as an integrated system. This eliminates the need for the user to program tests for each sample uniquely on each analyzer. Within the enGen (TM) Laboratory Automation System, the physical routing of samples to the correct location is also automatic. The Buffer Module functions either as a location for samples waiting for results or as a storage area for empty sample tube carriers. When a sample is presented to a clinical analyzer via the Bypass module and is metered for testing, the sample remains on the track system in the Buffer module while waiting for the test results to be gen
enGen (TM) Laboratory Automation Systems configured with TCAutomation'' Software version 3.5
Software anomaly: potential buffer timeout issues when using enGen (TM) Laboratory Automation Systems Configured with TCAutomation (TM) Software v3.5.
Worldwide Distribution: US Nationwide including Puerto Rico, and countries of: Australia, Bermuda, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela
enGen (TM) Laboratory Automation Systems (enGen)  with TCAutomation (TM) -- For in vitro quantitative measurement of a variety of analytes of clinical interest; for pre-analytical and post-analytical sample and data management. --- Background: The enGen (TM) Lab Automation System is a modification to VITROS Analyzers that includes the addition of an automated track sub-system (TCAutomation) for pre-analytical and post-analytical sample and data management. In addition to an Automated Track Sub-system, the enGen (TM) System includes one or more VITROS Chemistry, Immunodiagnostic and/or Integrated Systems (clinical analyzers) as well as a Data Management Subsystem (Middleware), and a Software Configuration (gsb) File. The enGen System is typically interfaced with a Laboratory Information System (LIS) via connectivity facilitated at the Data Management Subsystem level.  The Bypass Module is an analyzer specific module that interfaces clinical analyzers to the enGen System and allows for aspirating patient samples directly from the clinical analyzers. A sample tube carrier sensor in the Bypass Module is used to detect sample tube carriers as they leave the metering location of the Bypass.  If a tube carrier is not detected within a defined period of time (6.4 seconds) the next sample to be metered may not advance for processing.
TCA Software versions 2.6 , 3.2 and 3.5 configured with Bypass Modules for ADVIA Centaur (R), Abbott Architect (TM), VITROS (R) and/or Tosoh AIA (R) Systems
Software anomaly: potential for delay in the reporting of patient sample test results when using enGen (TM) Laboratory Automation Systems with TCAutomation (TM) Software v2.6, v3.2 and v3.5.
Worldwide distribution: US Nationwide including Puerto Rico and countries of: Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela.
VITROS  4600 Chemistry System, Product Code/Catalog Number 6802445   for in vitro diagnostic use.
Software Version 3.0 and lower; Serial Numbers J46000108 through J46000403
Potential for biased results when a Multiple Window (MW) code is associated with results generated by the VITROS  4600 Chemistry System, the VITROS 5600  Integrated System and the VITROS  5,1 Chemistry System. MW codes may be associated with results from any of the following VITROS Chemistry Products using multiple point (multipoint) rate measurements. The MicroSlide assays that could be affected are VITROS ALT, ALKP, AST, CHE, CK, GGT and LDH
Worldwide distribution including US Nationwide, Puerto Rico, Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela.
VITROS 5600 Integrated System, Product Code/Catalog Number 6802413 for in vitro diagnostic use.
Software Version 3.0 and lower; Serial Numbers J56000110 through J56001912
Domestic - 835 units, Foreign - 921 units
VITROS  5,1 FS Chemistry System and VITROS 5,1 FS Refurbished, Product Codes/Catalog Numbers 6801375, 6801890  for in vitro diagnostic use.
Domestic - 597 units, Foreign - 1381 units
Worldwide Distribution - US and the countries of Austria, Belgium, Germany, Spain, France, Great Britain, Italy, Netherlands and Sweden.
Boston Scientific, NovaGold High Performance Guidewire, Rx only, Sterilized using ethylene oxide, UPN M00552010 and M00552000, Manufactured by NeoMetrics Inc, 2605 Fernbrook Lane Suite J, Plymouth, MN 55447.   The NovaGold Guidewire is intended for use in selective cannulation of the biliary ducts including the common bile, pancreatic, cystic, right and left hepatic ducts, and to aid in the placement of diagnostic and therapeutic devices during endoscopic procedures.
Neo Metrics, Inc. is recalling NovaGold Guidewire because the tip may uncoil and / detach more frequently than anticipated. There have been no reports of illness or injury.
AR, CA, CO, FL, GA, IA, IN, KS, KY, MN, MS, NJ, NY, OH, OK, OR, TX, UT and VA.
Poco Pac Salad Dressing, Distributed by Diamond Crystal Brands, Inc., Savannah, GA 31405, and packaged in single serve packets of 9 or 12 grams (g) of product. Product is packed as follows: 500 ct-9g (Product Code: 86251), 200ct-9g (Product Code: 86242) and 200 ct-12g (Product Code: 86228).
48,143 cases/200 ct/9 gram pack per case
Worldwide Distribution and USA Nationwide - and the countries of Australia, Canada, China, France, Hong Kong, Italy, Japan, Mexico, Portugal, Spain, Switzerland, Taiwan,and Turkey.
Ultrasonic Transducer Kits For use with the Access Family of Immunoassay Systems*.    *The Access Family of Immunoassay Systems includes the Access 2, UniCel DxI 800 and UniCel DxI 600,  UniCel DxC 600i, and the UniCel DxC 880i, UniCel DxC 860i, UniCel DxC 680i, and UniCel DxC 660i  systems.
Access 2 Immunoassay Systems, Catalog Number:  81600N.  UniCel DxI 600 Access  Immunoassay Systems, Catalog Numbers:  A30260 and  A71460.  UniCel DxI 800 Access  Immunoassay Systems, Catalog Numbers:  973100 and  A71456.  UniCel DxC 600i SYNCHRON  Access Clinical Systems, Catalog Number:  A25640.    Catalog numbers for these  systems are included in the  respective DxI 600 and DxI  800 model numbers:  UniCel DxC   660i SYNCHRON  Access Clinical Systems,  UniCel DxC 680i SYNCHRON  Access Clinical Systems,  UniCel DxC 860i SYNCHRON  Access Clinical Systems,  UniCel DxC 880i SYNCHRON  Access Clinical Systems.
Beckman Coulter is initiating a field action for the Access Family of Immunoassay Systems because   some Ultrasonic Transducer Kits were potentially assembled with incorrect mounting screws.
Worldwide Distribution-USA (nationwide) including the states of AZ, CA, FL, NH, NJ, NY, PA, TX, and WI, and the countries of Canada and Netherlands.
BioDerm Liberty 3.0 External Male Catheter Specialty Type with integral collection chamber (Component: SKIN-PREP Protective wipes).    The recalled wipes are used on intact skin for applying skin protectant to the glands for control of male incontinence with an external, non-invasive and nonsterile device.
On 06/08/2011, BioDerm, Inc. issued a voluntary recall of a component skin wipes for the BioDerm Liberty 3.0 External male Catheter, BioDerm Liberty Pouch Clean & Dry External Male Catheter and BioDerm Safe n' Dry.  This component (wipes) were initially manufacturer by Smith & Nephew and recalled due to a potential bacterial contamination.
BioDerm Liberty Pouch Clean & Dry External Male Catheter Specialty Type with integral collection chamber (Component: SKIN-PREP Protective wipes).    The recalled wipes are used on intact skin for applying skin protectant to the glands for control of male incontinence with an external, non-invasive and nonsterile device.
BioDerm Safe n' Dry 21006 (Component: SKIN-PREP Protective wipes).   The recalled wipes are used on intact skin for applying skin protectant to the glands for control of male incontinence with an external, non-invasive and nonsterile device.
On 06/08/2011, BioDerm, Inc. issued a voluntary recall of a component (Smith and Nephew skin wipes) used in the BioDerm Liberty 3.0 External Male Catheter, BioDerm Liberty Pouch Clean & Dry External Male Catheter and BioDerm Safe n' Dry.  Potential bacterial contamination of Smith and Nephew skin wipes by one of their contract manufacturers.
Distributed USA (nationwide) including the states of CO, CT, MO, VT, NY, OH, NJ, FL, NC, VA, AL, MA, PA, and CA, and the country of  Canada.
Cooper Surgical TAMPA CATHETER 5 French 33 cm. Intended for Hysterosonography.  Model Number: 61-2005
Sterility of the device may be compromised due to  unsealed pouch
Marzipan - Pink, Orange and Green; Packed in 1 lb, (16 oz.) plastic containers and  and 10.5 lb. 4.76 kg)  pails.  Ingredient: Sugar, almonds, potassium sorbate, oil of bitter almonds.    Mandelin:  California Almonds and Almond Pastes,   Wasco California 93280
Undeclared Yellow #5 & 6 in Marzipan (Pink, Green, Orange).
The product was shipped nationwide, including: AL, AR, AZ, CA, CO, GA, IL, KS, KY, MA, MD, MI, MN, MO, MT, NC, NM, NV, NY, OH, OK, PA, SC, TN, TX, UT, and WI.    The product was also shipped to Canada and Australia.
KLM Hand & Body Moisturizing Lotion with oatmeal, aloe, and vitamin E sold in 800 mL bags, 1000 mL bottles, and 1 gallon bottles. Manufactured in the USA in a LEED Silver certified facility Kutol Products Co. Cincinnati, OH 45241. The product was also distributed under the Dominant 4 Protection brand name in Australia in 750 mL bags.
1 gallon - Kutol Catalog # 6207, Lot (L) 13020804; 800 mL bag - Kutol Catalog # 6265, Lot (L) 13062710; 1000 mL bottle - Kutol Catalog # 66236, Lot (L) 13062710; Dominant 750 mL bag - Kutol Catalog # 6226, Dominant Catalog # 15248, Lot (L) 13062710.
Catalog # 6207 - 240 units; Catalog # 6265 - 1392 units; Catalog # 66236 - 432 units; Catalog # 6226 - 1008 units.
Product has been found to contain Pseudomonas aeruginosa and Pseudomonas putida.
Stryker Instruments Div. of Stryker Corporation
Worldwide Distribution - US (nationwide)
Stryker 0.5mm Round Fluted Bur Sterile   Product Usage:  The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis.
Part Number 5820-10-5, Lot Number 13354017
There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite'' Attachments.
Stryker 1.0mm Round Fluted Bur  Sterile    Product Usage:  The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis.
Part Number 5820-10-10, Lot Number 14005017
Stryker 2.0mm Round Fluted Bur Sterile      Product Usage:  The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis.
Stryker 4.0mm Round Fluted Bur Sterile    Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis.
Part Number 5820-10-40, Lot Numbers 13344017
Stryker 6.0mm Round Fluted Bur Sterile    Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis.
Part Number 5820-10-60, Lot Numbers 13343017
Stryker 3.0mm Round Fluted Bur Soft Touch Sterile    Product Usage:  The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis.
Stryker 5.5mm Round Fluted Bur Soft Touch Sterile    Product Usage:  The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis.
Stryker 3.0mm Round Fluted Bur Aggressive Sterile    Product Usage:  The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis.
Stryker 4.5mm Round Fluted Bur Aggressive Sterile    Product Usage:  The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis.
Stryker 5.0mm Round Fluted Bur Aggressive Sterile    Product Usage:  The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis.
Stryker 5.5mm Round Fluted Bur Aggressive Sterile    Product Usage:  The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis.
Stryker 6.0mm Round Fluted Bur Aggressive Sterile    Product Usage:  The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis.
Part Number 5820-10-260, Lot Numbers 13346017
Stryker 2.0mm Tapered Round Elite Bur Sterile    Product Usage:  The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis.
Part Number 5820-10-320, Lot Numbers 14009017
Stryker 3.5mm Zyphr Elite Round Fluted Bur Sterile    Product Usage:  The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis.
Part Number 5820-10-635, Lot Numbers 13354017
Stryker 5.0mm Zyphr Elite Round Fluted Bur Sterile    Product Usage:  The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis.
Stryker 6.0mm Zyphr Elite Round Fluted Bur Sterile    Product Usage:  The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis.
Stryker 2.0mm Zyphr Elite Round Fluted Bur Sterile    Product Usage:  The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis.
Stryker 5.0mm Egg Bur Sterile    Product Usage:  The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis.
Part Number 5820-15-50, Lot Number 13343017
Stryker 6.0mm Egg Bur Sterile    Product Usage:  The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis.
Part Number 5820-15-60, Lot Number 14002017
Part Number 5820-17-50, Lot Number 13345017
Stryker 5.0mm Acorn Bur Sterile    Product Usage:  The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis.
Part Number 5820-30-50, Lot Number 13347017
Stryker 6.0mm Acorn Bur Sterile    Product Usage:  The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis.
Part Number 5820-30-60, Lot Number 13353017
Lindemann Drill Short, 1.6mm Sterile    Product Usage:  The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis.
Stryker 1.3mm Wire Pass Drill Sterile    Product Usage:  The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis.
Stryker 1.5mm Wire Pass Drill Sterile    Product Usage:  The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis.
Stryker 2.5mm x 3.6mm Neuro Drill Soft Touch Sterile    Product Usage:  The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis.
Stryker 3.0mm x 3.8mm Neuro Drill Soft Touch Sterile  Product Usage:  The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis.
Stryker 4.0mm x 5.1mm Neuro Drill Soft Touch Sterile    Product Usage:  The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis.
Stryker 3.0mm x 3.8mm Neuro Drill Sterile    Product Usage:  The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis.
Stryker 3.0mm x 3.8mm Precision Neuro Drill Sterile    Product Usage:  The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis.
Stryker 5.0mm Barrel Bur Sterile    Product Usage:  The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis.
Stryker 3.0mm x 3.8mm Neuro Drill Less Aggressive Sterile    Product Usage:  The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis.
Worldwide Distribution - USA including the states of  AL, AZ, AR, CA, CO, FL, IL, LA, ME, MI, MO, NY, OH, OR, TN, TX, VT and WI., and the country of Belgium.
Taut Operative Cholangiogram Catheter, 4.5FR (1.5mm) x 76cm   To facilitate the introduction of contrast media into the biliary ducts to obtain a cholangiogram during laparoscopic or open cholecystectomy.
Several complaints were received for the metal support tube missing from the cholangiogram catheter.
La Terra Fina All Natural Spinach & Kale Dip and Spread; Made with Greek Yogurt;  Net Wt. 10 oz. (.625 lb) 284 g  UPC 6 40410 51350 1;    La Terra Fina, Union City, CA.
59 cases (6 containers per case)lot 2014021, 57 cases lot 20140438, 126 cases Lot 2014505
Ingredient statement for one lot of Greek Yogurt Spinach Kale dip contains the ingredient statement for spinach dip.
United States:  Nationwide Foreign Countries:  Germany, Austria, Finland, Sweden, Australia, Qatar, Canada, Netherlands, New Zealand, Portugal, United Kingdom, Spain, Belgium, France, Switzerland, Norway, Czech Republic, Poland, Italy, Singapore, Denmark, Iceland, India, Saudi Arabia, Ireland, Oman, Bahrain, Japan, Israel, Malaysia, South Africa,   Turkey, Thailand, Latvia, Bulgaria, Indonesia, Slovenia, United Arab Emirates,   Hong Kong, Aruba, Chile, Lebanon, Korea, Kuwait, Taiwan, Argentina, Hungary, Luxembourg, Mexico, Gabon
IntelliVue MX40 Wearable Patient Monitor in use with the Philips IntelliVue Information Center iX (PIIC iX); 865350, 865351, 865352
Serial numbers within the following ranges that have the MX40 interfaces: 00700001 - US01443745 and US014Z1301 - US014Z1431
IntelliVue MX40 (part numbers 865350, 865352) with software revisions B.00 or B.01 may not resume alarming when the alarms are paused and the pause timer ends.
US Distribution including the states of CA, FL, OH and OK.
RUSCH Easy Cath Coude Kit, 10 FR, Rx Only, Sterile, Distributed by: Teleflex Medical, Research Triangle Park, NC 27708.   A tubular device that is inserted through the urethera and is used to pass fluids to or from urinary tracts.
Product Code: ECK103, Lot number: 02A1402484
Product was packaged with a straight catheter rather than the correct coude (curved) catheter.
Worldwide Distribution - USA including AL, AK, AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OR, PA, RI, SC, TN, TX, VT, VA, WA, WV, WI, WY, and Puerto Rico.  Internationally to Australia, Canada, France, Great Britain,and Guam.
Horizon Medical Imaging   Horizon Medical Imaging is a medical image and information management application that is intended to receive transmit, store, retrieve, display, print and process digital medical images, digital medical video, and associated medical information from various medical imaging systems.
Firm received a complaint that an unreported study performed that day could not be opened from the archive.
Dr. Reddy's Metoprolol Succinate Extended Release Tablets, USP 25 mg. 100-count bottle, Rx only,  Manufactured By: Dr. Reddy's Laboratories Limited, Batchupally - 500 090 India. NDC55111-466-01
Failed Dissolution Specifications: Failure of dissolution test observed at the 18 month time point.