Blood products, which may have reached unacceptable temperatures during shipment, were distributed.
Platelets Pheresis, Leukocytes Reduced, Irradiated
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Adipotrim XT, New Powerful Formula, 30 rapid release capsules per bottle, Dietary Supplement, www.adipotrim.com.
Marketed Without an Approved NDA/ANDA: FDA lab results found undeclared API Fluoxetine in this dietary supplement.
Nationwide Distribution - all states including DC and Puerto Rico.
Medtronic neurostimulators. Restore (37711), RestoreADVANCED (37713), RestoreADVANCED SureScan MRI (97713), RestoreSENSOR (37714), RestoreSENSOR SureScan MRI (97714), PrimeAdvanced SureScan MRI, (97702), RestoreULTRA (37712), RestoreULTRA SureScan MRI (97712), Itrel 4 (37703), Itrel 4 (37704), RestorePrime (37701), PrimeAdvanced (37702), Spinal Cord Stimulators for chronic pain.
The first released affected product was released to the market in April, 2005.
170,286 USa, 73,921 OUS for all devices.
Medtronic neurostimulators (used with pain and deep brain stimulation therapy) have a cycling feature that, when enabled, allows stimulation output to be toggled on and off based on the programmed settings.  The use of this feature is determined by the physician and set using the clinician programmer.   Current labeling indicates the use of cycling improves device longevity and recharge interval under all programming scenarios; however Medtronic has identified that in some situations the use of cycling can reduce the device battery longevity or recharge interval.    The only impact to patients is the potential for earlier than expected replacement or recharging at a greater than expected frequency.  The issue doesn't impact the device end of service alarms.
Medtronic  Activa RC (37612), Activa PC (37601), Activa SC (37602), Activa SC (37603), Activa PC+S (37604), Multi-program Rechargeable Neurostimulator for Deep Brain Stimulation for movement disorders.
Medtronic, External neurostimulator,  ENS (37021) & ENS (37022).  Including the external neurostimulators which are associated with software application run on the NVision Clinician Programmer and used during trialing for spinal cord stimulation (SCS) patients.
Cefoxitin for Injection and Dextrose Injection, 1 g in Duplex, 50 mL Container, Catalog No. 3123-11, For IV Use Only, Single Use, Sterile, Rx Only, B Braun Medical Inc, Irvine CA 92614-5895, NDC 0264-3123-11
Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
0.9 % Sodium Chloride Injection USP in PAB 50 mL partial fill in 100 mL PAB Container, Catalog No. S8004-5384, Rx Only, B Braun Medical Inc., Irvine CA 92614-5895, NDC 0264-1800-31
Ceftriaxone for Injection and Dextrose Injection, 1 g in Duplex,  50 mL Container, Catalog Number 3153-11, For IV Use Only, Single Dose, Sterile, Rx Only, B Braun Medical Inc., Irvine CA 92614-5895
Cefepime for Injections USP and Dextrose Injection USP, 1 g in Duplex, 50 mL Container, Catalog Number 3193-11, For IV Use Only, Single Dose, Sterile, Rx Only, B Braun Medical Inc., Irvine CA 92614-5895, NDC 0264-3193-11
Cefazolin for Injection USP and Dextrose Injections USP, 1 g in Duplex,  50 mL Container, Catalog Number 3103-11, For IV Use Only, Sterile, Single Dose, Rx Only, B Braun Medical Inc., Irvine CA 92614-5895, NDC 0264-3103-11
Cefazolin for Injection USP and Dextrose Injection USP, 2 g in Duplex,  50 mL Container, Catalog Number 3105-11, Rx Only, B Braun Medical Inc., Irvine CA 92614, NDC 0264-3105-11
0.9 % Sodium Chloride Injection USP, 1000 mL, Catalog No. S4000-SS, Rx Only, Sterile, Single Dose Container, B Braun Medical Inc., Irvine, CA 92614-5895, NDC 0264-4000-55
6.9% FreAmine HBC (Amino Acid Injection), partial fill container 750 mL in a 1000 mL container, Catalog No. S9350-58SS, Sterile, Single dose container, Rx Only, B Braun Medical Inc., Irvine, CA 92614-5895, NDC 0264-9350-55
15% Amino Acids Injection PBP Glass, 1000 mL, Catalog No. S3200-SS, Pharmacy Bulk Package, Not For Direct Infusion, For Intravenous Use, Sterile, Single Dose Container, Rx Only, B Braun Medical Inc., Irvine, CA 92614-5895, NDC 0264-3200-55
TrophAmine (10% Amino Acid Injection), 500 mL Container, Rx Only, Catalog No. S9341-SS, Sterile, Single Dose Container, B Braun Medical Inc., Irvine CA 92614-5895, NDC 0264-9341-55
ProcalAmine (3% Amino Acid and 3% Glycerin Injection with Electrolytes) 1000 mL Container, Rx Only, Catalog No. S9050, Sterile, Single Dose Container, B Braun Medical Inc., Irvine CA 92614-5895, NDC 0264-1915-07
Hyperlyte CR (Multi-Electrolyte Concentrate), 20 mL/dose, 250 mL Container, Catalog No. S9432, Rx Only, Sterile, B Braun Medical Inc., Irvine CA 92614-5895, In Canada Dist by: B Braun Medical Inc., Scarborough, Ontario M1H 2W4, NDC 0264-1943-20, Canada DIN 01924311
Human Chorionic Gonadotropin, EP (HCG) in 5 mu. 2 mu, and 1 mu packages, For use and distribution in prescription compounding, manufacturing, processing or repacking only in accordance with FDA regulations and applicable law.  Potency 5489.6IU/mg.  Packed by Medisca, Inc. Irving, TX, 75063, USA     NDC 38779-2673-1, NDC 38779-2673-2, and NDC 38779-2673-6.      Lot Numbers 101751/A, Exp: 05/16, CAS: 9002-61-3; 101752/A, Exp: 05/16,  CAS 9002-61-3;  and 101799/A, Exp: 05/16, CAS: 9002-61-3
Labeling: Label Error on Declared Strength; Firm states that erroneous potency information was found on the label.
Lidocaine HCl  Injection, USP, 2%, 20 mg per mL, packaged in 5-mL single-dose vials, 10 vials per box, Rx Only,  Hospira, Inc., Lake Forest, IL. 60045, NDC 0409-2066-05.
Presence of Particulate Matter- Confimed customer complaint of  particulates embedded in glass container and in contact with product solution.
IMMULITE /IMMULITE 1000 Systems TIE Total IgE, REF LKIE1, SMN 10380867, IVD --- Siemens Healthcare Diagnostics Products Ltd. Llanberis, Gwynedd, LL55 4EL, UK.   For in vitro diagnostic use with the IMMULITE, IMMULITE 1000, and IMMULITE 2000/ IMMULITE 2000 XPi Systems Analyzers - for the quantitative measurement of Total Immunoglobulin type E (IgE) in serum.
Siemens confirmed an overall average positive bias of 23% against the WHO 2nd IRP 75/502 with the IMMULITE Systems Total IgE assays.
IMMULITE2000 /IMMULITE 2000 XPi Systems TIE Total IgE, REF L2KIE2, SMN 10380873, and L2KIE6, SMN 10380872, IVD --- Siemens Healthcare Diagnostics Products Ltd. Llanberis, Gwynedd, LL55 4EL, UK.   For in vitro diagnostic use with the IMMULITE, IMMULITE 1000, and IMMULITE 2000/ IMMULITE 2000 XPi Systems Analyzers - for the quantitative measurement of Total Immunoglobulin type E (IgE) in serum.
Worldwide distribution: US (nationwide) and countries of: Argentina, Australia, Austria, Belgium, Brazil, Canada, China (People's Republic of), Czech.Rebuplik, Denmark, Estonia, France, Germany, Great Britain, Italy, New Zealand, Portugal, Spain, Switzerland, Turkey and Vatican City.
IMMULITE/IMMULITE 1000 Systems Androstenedione (Test Code AND), REF LKAO1, SMN 10381158, IVD,  100 test kit size --- Siemens Healthcare Diagnostics Products Ltd. Llanberis, Gwynedd, LL55 4EL, UK   For in vitro diagnostic use with the IMMULITE/IMMULITE 1000 and 2000 Systems Analyzers for the quantitative measurement of 4-androstenedione in human serum.
Siemens Healthcare Diagnostics confirmed over-recovery of samples with concentrations greater than 5.5 ng/mL with the IMMULITE/IMMULITE 1000 and IMMULITE 2000/IMMULITE 2000 XPi Androstenedione assays (LKAO1, L2KAO2). Siemens has determined that these lots are linear up to a concentration of 5.5 ng/mL, instead of 10 ng/mL as stated in the Instructions for Use (IFU). Quality Control materials at concentrations between 5.5 and 10 ng/mL will detect this issue.
IMMULITE 2000/2000 XPi Systems Androstenedione (Test Code AND), REF L2KAO2, SMN 10381188, IVD,  200 test kit size --- Siemens Healthcare Diagnostics Products Ltd. Llanberis, Gwynedd, LL55 4EL, UK    For in vitro diagnostic use with the IMMULITE/IMMULITE 1000 and 2000 Systems Analyzers for the quantitative measurement of 4-androstenedione in human serum.
Fluoxetine Capsules, USP, 20 mg, 30-count bottles, Rx only, Distributed by: Wal-Mart, Bentonville, AR  72716; Manufactured by: TEVA PHARMACEUTICALS USA, Sellersville, PA  18960; Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO  63045, NDC 68645-130-54, UPC 3 68645 13054 5.
Chemical Contamination: The recalling firm received notice that their supplier is recalling capsules due to complaints of capsules having an unusual odor.
Fluoxetine Capsules USP, 20 mg, packaged in a) 100-count bottles (NDC 50111-648-01), b) 500-count bottles (NDC 50111-648-02), c) 1000-count bottles (NDC 50111-648-03), and d) 2000-count bottles (NDC 50111-648-44), Rx only, Manufactured in Poland By: Pliva Krakow Pharmaceutical Company S.A., Krakow, Poland; Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA  18960.
Chemical Contamination: Recall due to a customer complaint trend regarding capsule odor.
Fluoxetine Capsules USP, 10 mg, 100-count bottles, Rx only, Manufactured in Poland By: Pliva Krakow Pharmaceutical Company S.A., Krakow, Poland; Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA  18960, NDC 50111-647-01, UPC 3 50111-647-01 5.
Nationwide Distribution -- AK, AL, AR, AZ, CA, CO, CR, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY.
Abbott Acclaim Infusion Pump   Designed to deliver parenteral infusions including whole blood or red blood cell components and enteral fluids using a wide variety of standard administration sets and fluid containers.
Hospira has received customer reports of broken door assemblies on the Hospira/Abbott Acclaim Encore infusion pumps. If the door assembly breaks, it may prevent the door from closing properly and unrestricted flow may occur. If the door cannot be closed, the pump cannot be used which can result in a delay in therapy.
Hospira Acclaim Encore Infusion Pump    Designed to deliver parenteral infusions including whole blood or red blood cell components and enteral fluids using a wide variety of standard administration sets and fluid containers.
Hospira has received customer reports of broken door assemblies on the Hospira/Abbott Acclaim Encore infusion pumps.  If the door assembly breaks, it may prevent the door from closing properly and unrestricted flow may occur. If the door cannot be closed, the pump cannot be used which can result in a delay in therapy.
Dianeal PD-2 Peritoneal Dialysis Solution with 1.5% Dextrose, 6000 mL Ambu-Flex II container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code L5B9710, NDC 0941-0411-11
Non-Sterility: Complaints of leaks and particulate matter identified as mold in the solution bag and the overpouch.
Lupron Depot (Leuprolide Acetate for Depot Suspension) Single Dose Administration Kit with prefilled dual-chamber syringe, 22.5 mg for 3-month administration, Rx only, Manufactured for: AbbVie Inc., North Chicago, IL  60064; by: Takeda Pharmaceutical Company Limited, Osaka, Japan 540-8645; NDC 0074-3346-03, UPC 3 00743 34603 9.
Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc needle stick protection device.
Lupron Depot (Leuprolide Acetate for Depot Suspension) Single Dose Administration Kit with prefilled dual-chamber syringe, 45 mg for 6-month administration, Rx only, Manufactured for: AbbVie Inc., North Chicago, IL  60064; by: Takeda Pharmaceutical Company Limited, Osaka, Japan 540-8645; NDC 0074-3473-03, UPC 3 00743 47303 2.
LUPRON DEPOT-PED (Leuprolide Acetate for Depot Suspension) Single Dose Administration Kit with prefilled dual-chamber syringe, 11.25 mg for 3-month administration, Rx only, Manufactured for: AbbVie Inc., North Chicago, IL  60064; by: Takeda Pharmaceutical Company Limited, Osaka, Japan 540-8645; NDC 0074-3779-03, UPC 3 00743 77903 5.
Lupron Depot (leuprolide acetate for depot suspension) Single Dose Administration Kit with prefilled dual-chamber syringe, 11.25 mg for 3-Month administration, Rx only, Manufactured for: AbbVie Inc., North Chicago, IL  60064; by: Takeda Pharmaceutical Company Limited, Osaka, Japan 540-8645; NDC 0074-3663-03, UPC 3 00743 66303 7.
Lupron Depot (Leuprolide Acetate for Depot Suspension) Single Dose Administration Kit with prefilled dual-chamber syringe, 7.5 mg for 1-month administration, Rx only, Manufactured for: AbbVie Inc., North Chicago, IL  60064; by: Takeda Pharmaceutical Company Limited, Osaka, Japan 540-8645; NDC 0074-3642-03, UPC 3 00743 64203 2.
Defective Delivery System: Some Lupron Depot Kits may containin a syringe with a potentially defective LuproLoc needle stick protection device.
Worldwide Distribution -- USA, including the states of CA, IN, LA, MA, OH, TX, and WI, and the countries of Australia, China, France,  Germany, Japan, Netherlands, and the United Kingdom.
ExacTrac 6.0 is a patient positioning and monitoring system.   Model/catalogue numbers:  20833B EXACTRAC 6.0 IR POSITIONING SOFTWARE  49936 ET SOFTWARE UPDATE 6.0.X TO 6.0.3  49926B ET UPGRADE SOFTWARE 3.X TO 6.0 (IR+XR)  49934A EXACTRAC UPGRADE 5.5 TO 6.0 BASIC  49927B ET UPGRADE SOFTWARE 4.X TO 6.0 (IR+XR)  49928B ET UPGRADE SOFTWARE 5.X TO 6.0 (IR+XR)  49933B ET UPGRADE TRUEBEAM 5.5 TO 6.0 LIMITED  49973B ET DATA PREP / REVIEW SYSTEM  49998B ET 6.0 DATA PREP/REVIEW SYSTEM UPG. KIT  49996B ET UPGRADE SOFTWARE X.X TO 6.0 SW ONLY  49997B ET UPGRADE SOFTWARE 5.5 TO 6.0 LIMITED
41 systems (13 systems in US; 28 systems to foreign countries)
When using multiple radiation treatment targets within a single plan, the ExacTrac v.6.0.3 might position the patient to an unintended radiation treatment point.  As a result, there is a possibility that the radiation treatment dose may be delivered to the unintended target position.
Losurdo IMPORTED GRATED PECORINO ROMANO, NET WT. 80 OZ. (5 LB.) 2.27 Kg, UPC 0 75009 00232 4.  Product packaged within black plastic bag, with 5 bags per carton (20 LB) total per carton.  Distributor LOSURDO FOODS, INC. 20 Owens Roads Hackensack, NJ 07601.
Losurdo Foods has recalled one lot of Grated Cheese Pecorino Romano due to Listeria monocytogenes contamination.
US: CO, MO, NY, PA.   OUS:  CANADA, UNITED KINGDOM, TAIWAN, PORTUGAL, LEBANON.
Invitrogen by Life Technologies, AllSet+ Gold SSP HLA ABC Low Res Kit, REF 54340D.
HLA typing assay, associated with false typing assignments, was distributed.
Venlafaxine Hydrochloride Extended-Release Tablets, 150 mg, packaged in a) 30-count bottles (NDC 41616-758-83, UPC 3 41616 75883 2); and b) 90-count bottles (NDC 41616-758-81, UPC 3 41616 75881 8), Rx only, Distributed by: Caraco Pharmaceutical Laboratories, Ltd., 1150 Elijah McCoy Drive, Detroit, MI  48202; Manufactured at: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India.
Failed Dissolution Specifications: Stability results found the product did not meet the drug release dissolution specifications.
Venlafaxine Hydrochloride Extended-Release Tablets, 37.5 mg, packaged in a) 30-count bottles (NDC 41616-760-83, UPC 3 41616 76083 5); and b) 90-count bottles (NDC 41616-760-81, UPC 3 41616 76081 1), Rx only, Distributed by: Caraco Pharmaceutical Laboratories, Ltd., 1150 Elijah McCoy Drive, Detroit, MI  48202; Manufactured at: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India.
Fisherbrand Sterile Swabs, Calcium Alginate Fiber Tipped Aluminum Applicator Swab, .025 and .035 in Diameter, all lots, 100 per pack   Fisherbrand Sterile Swabs, Calcium Alginate Fiber Tipped Plastic Applicator Swab, all lots, 100 per pack    Fisherbrand Sterile Swabs, Calcium Alginate Fiber Tipped Wood Applicator Swab, all lots, 100 and 200 per pack    culture collection and industrial surfaces
A customer reported the presence of an organism in a lot of Calcium Alginate Fiber Tipped Wood Applicator Swab.
Blood and Blood Products for Reprocessing
Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, District of Columbia, Guam, Puerto Rico, and Internationally to Australia, Austria, Bahrain, Belgium, Canada, Chile, Egypt, France,  Germany,  Greece, Hong Kong, Italy, Jordan, Kuwait, Lebanon, Libya, Luxemburg, Netherlands, New Zealand, Oman, Portugal, Saudi Arabia,  Slovenia, South Africa, Spain, Switzerland, Turkey, United Arab Emirates, and United Kingdom.
GemStar Docking Station, used with GemStar infusion pump, in combination with other GemStar accessories such as the GemStar Lock Box and patient bolus cord.  The docking station is also used for hosting the GemStar pump for general infusions.  List Numbers: 13075-XX-XX
26,765 docking stations total (6866 in US)
There are two situations that may occur when using the GemStar Docking Station, List Number 13075-XX-XX, in conjunction with the GemStar infusion pump: 1) when the Docking Station is used in conjunction with a GemStar Phase 3 pump (List 13000-XX, 13100-XX, or 13150-XX) the potential exists for the GemStar Phase 3 pump to fail to power up while connected to the Docking Station, and 2) when either a GemStar Phase 3 (List 13000-XX, 13100-XX, or 13150-XX)or GemStar Phase 4 pump (List 13086-XX, 13087-XX, or 13088-XX) is used in conjunction with both a Docking Station and an External Battery Pack accessory (List 13073-XX) there exists a possibility that the GemStar pump will display error code 11/003 and give an audible alarm indicating excessive input voltage from the external sources. If the GemStar pump detects what is perceived to be more than 3.6 Volts measured on the external voltage input, the pump will stop the infusion and alarm both with an audible sound as well as a visual alarm.
GLYBURIDE and METFORMIN HYDROCHLORIDE Tablets USP, 5mg/500mg, 500 count bottle, Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960,   NDC: 0093-5712-05
This recall was initiated because laboratory testing was not followed in accordance with GMP requirements.
INDOMETHACIN Capsules USP, 25 mg 100 count bottle, Rx only , Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC 0093-4029-01
INDOMETHACIN Capsules USP, 50 mg, a) 100 count bottle, (NDC 0093-4030-01), b) 500 count bottle, (NDC 0093-4030-05), Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960
METHYLDOPA Tablets USP, 500 mg, 100 count bottle, Rx only, Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960,  NDC 0093-2932-01
Phosphatidylcholine Solution for Injection, 50 mg/ mL, 50 mL Vial, Rx Only, Not for Resale.  John Hollis Pharmacy, 110 20th Avenue N, Nashville, TN 37203.
Labeling: Incorrect Expiration Date; Expiration date is earlier than listed on vial.
Papaverine 60 mg, Phentolamine 4 mg, and Atropine 0.3 mg Solution, 10 mL Vial, Rx Only.  Not for Resale.  John Hollis Pharmacy, 110 20th Avenue N, Nashville, TN 37203.
Polidocanol 1% Solution, 50 mL Vial, Rx Only, Not for Resale.  John Hollis Pharmacy, 110 20th Avenue N, Nashville, TN 37203.
Polidocanol 3% Solution, 50 mL Vial, Rx Only, Not for Resale. John Hollis Pharmacy, 110 20th Avenue N, Nashville, TN 37203.
Human Corneas, recovered from donors whose donor eligibility was not determined by using appropriate FDA-licensed, approved, or cleared donor screening tests, in accordance with the manufacturer's instructions, to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents or diseases, were distributed.
US nationwide, Canada, France, Greece, Israel, Italy, Poland, Spain, Brazil, China, Japan, Malaysia, Singapore, and Thailand.
Micro SSP'' Allele Specific HLA Class I DNA Typing Tray-C*02, Catalog Identification: SSPR1-C02. BK960062
Catalog Identification: SSPR1-C02. Micro SSP'' Allele Specific HLA Class I DNA Typing Tray   C*02  Catalog Identification: SSPR1-C02  Article Number: SSP_DNAT_PI Rev 18  Lot number: 002, batches 001-006 (Batch 002 not distributed).
Schwan's Global Supply Chain, Inc. (This correction has already been made)
Florida, Texas, Illinois, New Jersey, Maryland, Virginia.   Consignee list to be provided later.
Holiday Foods,  Cheddar Cheese Puffs, 4800308, UPC 70220748003081, 100 PCS, Not Fully Cooked - Cook Before Eating, Keep Frozen, For Institutional Use Only, Prepared by Holiday Food Inc, Hollywood, Florida 33020.
Schwans Food Company is recalling Cheddar Cheese Puffs and Gourmet Cold Canapes Assortment manufactured by Holiday Foods, Inc that were prepared with ingredients  which are being recalled by Parker Farm Inc. because of the potential of  Listeria monocytogenes contamination.
Holiday Foods Gourmet Cold Canapes Assortment, 4800361, UPC 70220748003616, 100 OCS. Keep Frozen, For Institutional Use Only, Defrost in Refrigerator for Approximately 3 hours Before Serving, Consume Immediately. Prepared by Holiday Foods Inc, Hollywood, Florida 33020.
Nationwide, Puerto Rico, and foreign distribution to Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico,  Panama, Singapore, Spain and Venezuela.
VITROS Chemistry Products Specialty Diluent, REF 855 9825, 6 x 3 mL, IVD --- Ortho-Clinical Diagnostics, Inc. Rochester, NY
1656 distributed (1200 went to warehouse in France)
Ortho Clinical Diagnostics (OCD) confirmed the potential for lower than expected C-Reactive Protein (CRP) results only to be generated when using VITROS Chemistry Products Specialty Diluent (Lot F3168) or VITROS Chemistry Products FS Diluent Pack 3 (Lot 01-3266).  The VITROS Instructions for Use states that if the if a C-reactive protein concentration exceeds the systems measuring (reportable or dynamic) range, dilute the sample with VITROS Specialty Diluent or a patient sample containing a low concentration of CRP. An initial threefold dilution is recommended. Internal testing determined that results using VITROS CRP Slides have the potential for approximately 51% bias using a 3x dilution factor.
VITROS Chemistry Products FS Diluent Pack 3, REF 680 1754, 3 x 45 mL, (D1)/15 mL (D2),  IVD --- Ortho-Clinical Diagnostics, Inc. Rochester, NY, 14626
1042 distributed (220 went to warehouse in France)
US Nationwide Distribution - in the states of CA, CO, FL, GA, LA, MI, MN, MO, OH, OR, PA, PR, TX, UT, VA, WA and WY.   Product was distributed outside the US to: Australia, China,  Figi, France, Great Britain, Italy, Japan, Korea, Maylasia, Sweden, South Africa, Spain.
The Osteo-Clage System consists of stainless steel cable/sleeves and compression plates. . 2.0 mm x 850mm SS Cable/Sleeve; Part Number 01-0020-S 2.0 mm SS Sleeve Only; Part Number 01-0022-S 8, 7 hole, SS compression plate; Part Number 02-2007-S 10, 9 hole, SS compression plate; Part Number 02-2009-S Product Usage: The Osteo-Clage Stainless Steel Bone Plate is an implantable straight, rigid stainless steel plate. It is used in conjunction with 4.5mm Cortical bone screws to provide compression across bone fractures. The Osteo-Clage Cerclage Wire Crimp sleeve is used in conjunction with the bone plate in cerclage fixation procedures.
141 units in the US; 294 units outside the US.
Acumed is voluntarily recalling specific lot numbers of Osteo-Clage Stainless Steel Bone Plates and Tension Band Pins due to the manufacturing of these devices with a grade of stainless steel that is not within specifications.
The Acumed Tension Band Pin is a fixation pin which is .0625'' in diameter and is available in lengths between 35mm and 90mm.  It is to be used in conjunction with commonly used orthopedic wire.   50.0 mm Tension Band Pin;  Part Number 30-0097  70.0 mm Tension Band Pin;  Part Number 30-0098  90.0 mm Tension Band Pin;  Part Number 30-0099  50.0 mm Tension Band Kit;  Part Number TB-1550K-S  70.0 mm Tension Band Kit;  Part Number TB-1570K-S  90.0 mm Tension Band Kit;  Part Number TB-1590K-S    Product Usage:  Acumed Tension Band Pin is intended to be used with orthopedic wire to address malleolar, patella, and olecranon fractures in tension band wiring procedures. This device is not intended for usage in the spine.
2544 unit in the US and 3584 units outside the US
Certain lots of Acumed Tension Band Pins are being recalled because the implantable product was manufactured with a grade of stainless steel that is not within specifications.
Alfa Wassermann Diagnostic Technologies, LLC.  ACE ALT Reagent.     Product Usage:  For quantitative determination of ALT in serum and lithium heparin plasma using ACE, ACE Alera and ACE Axcel Clinical Chemistry Systems. This test is intended for use in clinical laboratories and physician office labs.
ACE ALT Reagent (Product reorder number SA1046 Lot F3604)
Alfa Wassermann Diagnostic Technologies, LLC.  ACE AST Reagent.     Product Usage:  For quantitative determination of AST in serum and lithium heparin plasma using ACE, ACE Alera and ACE Axcel Clinical Chemistry Systems. This test is intended for use in clinical laboratories and physician office laboratories.
ACE AST Reagent Product reorder numbers SA1047 (Lot F3609) and RX1047 (Lot F3610)
Triple Cleaned Corn, 50 LBS NET, Packaged by:  Southern Seed and Feed, Macon, MS
None.  Recall includes two shipments delivered 03/04/2014 and 03/07/2014
Sample of product found Fumonisin above the recommended limit of 5 PPM.
Worldwide Distribution -- USA, and the countries of Australia, Austria, Belgium, Brazil, Canada, China, Denmark, Egypt, France, Germany, Hong Kong, Ireland, Italy, Korea, Lebanon, Malaysia, Netherlands, Norway, Pakistan, Portugal, Russia, Singapore, Spain, Sweden, Thailand, & United Kingdom.
Nuclear gamma cameras (ADAC Vertex Plus, ADAC Solus, ADAC Vertex V60 & ADAC Vertex Classic) Philips Medical System, Cleveland, OH 44143.   Used to produce images depicting the anatomical distribution of single photon and positron emitting radioisotopes with the human body for interpretation by medical personnel.
Slippage of the radius drive belt in the relative 180 degree orientation of the superior positioned detector head will allow the detector head to drift down and potentially come in direct contact with the patient.
Worldwide Distribution - USA (nationwide) including the countries of Australia,  Canada, and Switzerland.
Integra CUSA Excel Disposable Wrench.  Catalog Number C5601. The CUSA Excel+ Sterile 23 kHz Torque Wrench is an accessory used with the CUSA Excel+ System ultrasonic surgical instrument. The torque wrench is used to properly secure the CUSA tip to the CUSA handpiece in the sterile field.
3,984 devices packaged as 6 devices / box (664 boxes)
Some 23 kHz Torque Wrenches were incorrectly assembled and contained a 36 kHz Hex Wrench Insert instead of the 23 kHz Hex Wrench Insert.
Distributors in GA, PA, MD, IL, CA, IA, CT, TX,
RISING MOON  ORGANICS BASIL ASIAGO PINE NUT PESTO RAVIOLI; 8 OZ PACKAGE (227g)  Keep Frozen  USDA Organic:    Distributed by Rising Moon Organics  313 Iron Horse Way  Providence, RI 02908
900 CASES, 6 UNITS PER CASEor 5400 TOTAL UNITS)
Basil, Asiago & Pine Nut Pesto Ravioli is labeled with the ingredient statement for  Itsy Bitsy ravioli and therefore does not include Pine Nuts in the ingredient or allergen statement.
Potassium Chloride for Inj. Concentrate, USP, 40 mEq (2  mEq/mL), 20 mL Single-dose Fliptop Vial, For IV use, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA
Presence of Particulate; red and black particulate within the solution and embedded within the plastic vial identified as iron oxide
Avera McKennan Hospital & University Health Center
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Red Blood Cells (Apheresis) Leukocytes Reduced
Blood products, with unacceptable cell recovery rates, were distributed.
Worldwide Distribution-USA including the states of CA, TX, FL, MO, NY, MI, MO, and AZ and Seoul, Korea.
Anti EpCam PE - Analyte Specific Reagent.   Anti-EpCAM is directed against human epithelial adhesion molecule that has been identified as a 40 -kilodalton (kd) protein in Western Blotting.
Catalog number 347211; Lot number 3295974 - expiry date 2015-09-30;  Lot number 3259822 - expiry date 2015-09-30.
Two lots of Anti EpCAM PE-Analyte Specific Reagent are mislabeled - the actual antibody present in the vial is CD9 PE.
Distributed in the states of CA, VT, NC, DO, TX, FL, PA, OR, AZ, IL, ID, and VA.
PolypVac 3.5mm Microdebrider; Catalog Number FG-000016; contents: 1 Microdebrider, 1 Stylet, 1 filter. Sterile.  Used for the excision of polyps in the nasal passageways and in sinuses for which access has been previously established.
Lot Number: LFG-111813-1; Expiry date: June 2014; LFG020614-01, Expiry date: September 2014.
The reciprocation mechanism in the PolypVac Microdebrider may turn off prematurely due to a component failure in the device handle.
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
Pastene MAFALDINE 5, 16 oz cellophane bag Imported from Italy. Imported by the Pastene Company, Canton, MA   Item Number: 7062  UPC: 066086070627
Semolina pasta fails to declare the allergen''wheat''
Pastene GEMELLI 104, 16 oz cellophane bag Imported from Italy. Imported by the Pastene Company, Canton, MA   Item Number: 7063  UPC: 066086070634
Pastene REGINE 10, 16 oz cellophane bag.  Imported from Italy. Imported by the Pastene Company, Canton, MA    Item Number: 7064  UPC: 066086070641
Pastene FARFALLINE 78,  16 oz cellophane bag.  Imported from Italy. Imported by the Pastene Company, Canton, MA    Item Number: 7067  UPC: 066086070672
Pastene ITAL TAGLIATELLE VERDI #80, 16 oz cellophane bag.  Imported from Italy. Imported by the Pastene Company, Canton, MA    Item Number:7070  UPC: 066086070702
Pastene ITAL CAPELLI D'ANGELO #83, 16 oz cellophane bag.  Imported from Italy. Imported by the Pastene Company, Canton, MA    Item Number:7074  UPC: 066086070740
Pastene ITALIAN SPAGHETTI    #15,  16 oz cellophane bag.  Imported from Italy. Imported by the Pastene Company, Canton, MA    Item Number:7075  UPC: 066086070757
Pastene  ITALIAN LINGUINE   #6,  16 oz cellophane bag.  Imported from Italy. Imported by the Pastene Company, Canton, MA    Item Number:7077  UPC: 066086070771
Pastene  ITALIAN ZITI RIGATI  #20,  16 oz cellophane bag.  Imported from Italy. Imported by the Pastene Company, Canton, MA    Item Number:7079  UPC:066086070795
Pastene ITALIAN FUSILLI  #28,   16 oz cellophane bag.  Imported from Italy. Imported by the Pastene Company, Canton, MA    Item Number:7081  UPC: 066086070818
Pastene ITALIAN CAPELLINI    #17, 16 oz cellophane bag.  Imported from Italy. Imported by the Pastene Company, Canton, MA    Item Number:7082  UPC: 066086070825
Pastene ITALIAN RIGATONI   #31 , 16 oz cellophane bag.  Imported from Italy. Imported by the Pastene Company, Canton, MA    Item Number:7083  UPC: 066086070832
Pastene ITALIAN SHELLS  #25 , 16 oz cellophane bag.  Imported from Italy. Imported by the Pastene Company, Canton, MA    Item Number:7084  UPC: 066086070849
Pastene ITALIAN DITALI  #45 , 16 oz cellophane bag.  Imported from Italy. Imported by the Pastene Company, Canton, MA    Item Number:7085  UPC: 066086070856
Pastene ITALIAN STELLINE   #59  , 16 oz cellophane bag.  Imported from Italy. Imported by the Pastene Company, Canton, MA    Item Number:7086  UPC: 066086070863
Pastene ITALIAN TRIVELLA #69 , 16 oz cellophane bag.  Imported from Italy. Imported by the Pastene Company, Canton, MA    Item Number:7087  UPC: 066086070870
Pastene  ITAL NIDI #81 ,16 oz cellophane bag.  Imported from Italy. Imported by the Pastene Company, Canton, MA    Item Number:7090  UPC: 066086070900
Pastene  ITALIAN FARFALLE  #66 ,16 oz cellophane bag.  Imported from Italy. Imported by the Pastene Company, Canton, MA    Item Number:7091  UPC: 066086070917
Pastene ITALIAN PAPPARDELLE ,16 oz cellophane bag.  Imported from Italy. Imported by the Pastene Company, Canton, MA    Item Number:7092  UPC: 066086070924
Pastene ITALIAN BUCATINI,16 oz cellophane bag.  Imported from Italy. Imported by the Pastene Company, Canton, MA    Item Number:7095  UPC: 066086070955
Pastene ITALIAN ORECCHIETTE ,16 oz cellophane bag.  Imported from Italy. Imported by the Pastene Company, Canton, MA    Item Number:7097  UPC: 066086070979
Pastene ITAL LONG FUSILLI ,16 oz cellophane bag.  Imported from Italy. Imported by the Pastene Company, Canton, MA    Item Number:7098  UPC: 066086070986
Pastene ITAL TRICOLOR FARFALLE ,16 oz cellophane bag.  Imported from Italy. Imported by the Pastene Company, Canton, MA    Item Number:7088  UPC: 066086070887
Semolina pasta fails to declare the allergen ''wheat''
Pastene ITAL SPIRAL TRI COLOR,16 oz cellophane bag.  Imported from Italy. Imported by the Pastene Company, Canton, MA    Item Number:7093  UPC: 066086070931
Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30 count bottle, OTC Manufactured by Sun Pharma, Gujarat, India, NDC 47335-343-83
Failed Impurities/Degradation Specifications: Stability testing found the product may not meet the drug release specification through expiry.
Children's Cetirizine Hydrochloride Chewable Tablets, 10 mg,  30 count bottle, OTC,  Manufactured by Sun Pharma, Gujarat, India, Distributed Chain Drug Consortium, Boca Raton, FL,  NDC 47335-344-83
Worldwide Distribution - US Nationwide in the states of CA, CO, GA, LA, IL, MA, MI, MN, MO, NC, and in the countries of Ireland and Singapore.
CAPIO, Monodeck, Violet Monofilament Polydioxanone Suture, 1 x 48 inches (122cm) Absorbable Surgical Suture, Rx Only, Teleflex Medical.   Product Code: 833-137.
The product did not meet minimum and/or average minimum Teleflex resorption strength requirements.
Dekna-lok, 1 x 17.78 cm, Violet Braided Polyglycolic Acid Coated Suture, Synthetic Absorbable Surgical Suture USP, Rx Only, Sterile. Teleflex Product Code: 200101-01.
0.9% Sodium Chloride Irrigation, USP, 1000 mL,Not for Injection,  Manufactured by Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-0048-04.
Presence of Particulate Matter: Nylon fibers found in a bottle of 0.9% sodium chloride for irrigation.
Risperidone Oral Solution, 1 mg/mL, 30 mL bottle, Rx only, Manufactured by Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for Apotex Corp., Weston, FL 33326, NDC 60505-0380-1.
Failed Impurities/Degradation Specifications: Out of Specification for an impurity at the 18 month stability time point.
The entire lot was sold under two (2) sales orders with the final shipment taking place on 09/25/2013.
Fish Oil Softgel Capsules in white High Density Poly-Ethylene bottles labeled in part: ''Major [brand] Fish Oil Cholesterol Free 1000 MG *** 100 Softgels *** Distributed by Major Pharmaceuticals ***Livonia, MI 48150 USA ***''.
Conjugated Linoleic Acid (CLA) softgel capsules and Fish Oil capsules were found mixed together in a retail bottle labeled as1000 mg Fish Oil soft gel capsules.
Maximum Strength/Non-Drowsy Tussin DM Adult Maximum Strength, Cough Cold, Dextromethorphan HBr, USP, 10 mg (Cough Suppressant) , Guaifenesin, USP, 200 mg  (Expectorant), 4, 8 fl oz bottles , OTC only, labeled as A) CareOne 8 fl oz bottle, Distributed by American Sales Company, Lancaster, NY 14086, UPC 341520339677, B) Our Family 4 fl oz bottle, Distributed by Nash Finch Company, NFC Brands, MPLS, MN 55435, UPC 070253579523, C) Premier Value 4, 8 fl oz bottle, Distributed by Chain Drug Consortium, LLC., Boca Raton, FL 33431, 4 fl oz UPC 840986024719;  8 fl oz UPC 840986024726, NDC 68016-177-XX,  D) Rexall  4 fl oz bottle, Packaged for Dolencorp, LLC, Goodlettsville, TN 37072, UPC 715256714044, E) Safeway  4 fl oz, Distributed by Safeway INC, Pleasanton, CA 94566-0009, UPC 321130763581; F) Select Brand 4, 8 fl oz, Distributed by Select Brand Distributers, Pine Bluff, AR 71603, 4 fl oz UPC 015127024303; 8 fl oz UPC 015127024310.
Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles.
To wholesale distributors and retailers located Nationwide.
Sevoflurane, USP (Inhalation Anesthetic), Rx Only, 250 mL Amber Bottle. Manufactured By: Piramal Critical Care, 3950 Schelden Circle, Bethlehem, PA 18017.  NDC: 66794-015-25.
Failed pH Specifications: product was too acidic.
Worldwide Distribution - USA including IN and Internationally to AUSTRALIA, CANADA, CHILE, FRANCE, ITALY, JAPAN, KOREA, KUWAIT, NEW ZEALAND, PANAMA, POLAND, SAUDI ARABIA, SPAIN, SWEDEN, SWITZERLAND, UNITED KINGDOM,
GE Healthcare, CardiacVX [CardiacVX (1.1.0 Ext. d) and CardiacVX Flow (1.1.0 Ext. d) analysis software running on Advantage Workstation]. Model #'s 5434389-2 and 5434384-2. The GE Cardiac VX for MRI is an analytical software tool, which provides reproducible tools for the review and reporting of medical images.
GE Healthcare has recently become aware of a potential safety issue due to higher than actual flow values reported on CardiacVX and CardiacVX Flow running on Advantage Workstation.
US: CA, FL, MD, MA, MI, MS, NY,NC, PA.   OUS: TAIWAN RUSSIA, JAPAN, ISRAEL, GREECE, GERMANY, FINLAND, UNITED ARAB EMIRATES.
AllSet+'' Gold SSP HLA- A*23/24 High Res Kit (54160D)  A*23 SSP UniTray Kit  (471702)    A*23 SSP UniTray Kit with Taq Polymerase (471712)
Children's Triacting Night Time Cold & Cough with PE  (diphenhydramine hcl and phenylephrine hcl), Grape Flavor, For Ages 6 to 11, 4 fl oz Bottles, liquid. Labeled A) aaron health KIDS, Manufactured by: Aaron Industries, P.O. Box 801, Lynwood, CA 90262. UPC: 7 15256 72204 9. B) FAMILY wellness, Distributed By: Family Dollar Services, Inc., 10401 Monroe Rd, Matthews, NC 28105.  UPC: 0 32251 03394 0. C) Good Neighbor Pharmacy. Distributed By: AmerisourceBergen, 1300 Morris Drive, Chesterbrook, PA 19087. NDC: 24385-121-25. D) Pedia Care. Distributed by Medtech Products Inc., Irvington, NY 10533.  UPC: 8 14832 01354 7.  E) Quality Choice. Distributed by Quality Choice, Novi, MI 48376-0995. NDC: 63868-0368-04.  F) Safeway.  Distributed by Safeway Inc. P.O. Box 99, Pleasanton, CA 94566. NDC: 21130-152-04.  G) Well at Walgreens. Distributed By: Walgreen Co, 200 Wilmot Rd., Deerfield, IL 60015. NDC: 0363-0152-04.
Presence of Precipitate: Small amounts of diphenydramine and mannitol precipitated out of solution.
Worldwide Distribution-USA including DC and the states of AZ, CA, CT, FL, GA, IL, HI, KY, MD, MA, MI, MS, MO, NJ, NY, NH, NC, ND, OH, OK, OR, PA, SC, TX, VA, WA, WI, and WY, and the countries of  Algeria, Australia, Austria, Belgium, Brazil, Canada, China, Colombia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Israel, Italy, Japan, Kazakhstan, Mexico, Netherlands, New Zealand, Peru, Poland, Portugal, Russia, Saudi Arabia, South Korea, Span, Sweden, Switzerland, Taiwan, Thailand, Turkey, and United Kingdom.
HexaPOD evo RT Couchtop.   To support and aid in positioning a patient during radiation therapy.
If screws are not properly tightened with a torque wrench they may become loose over time.
Glytone Acne, acne treatment facial cleanser, 2% Salicylic Acid, 200 mL/6.7 FL Oz Bottle, Distributed by Genesis Pharmaceuticals, Inc. a subsidiary of Pierre Fabre, Parsippany, NJ 07054, UPC 3 04760-00413-2
Failed Stability Specifications: Out of specification results for viscosity in one lot of Glytone Acne Treatment Facial Cleanser.
Worldwide Distribution -- USA, except ND, RI and WY, and including DC, Guam, and Puerto Rico; and, the countries of ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA,AZERBAIJAN, BAHRAIN, BELARUS, BELGIUM, BRAZIL, CANADA, CAYMAN ISLANDS, CHINA, CROATIA, CZECH REPUBLIC, DENMARK, EGYPT, FINLAND, FRANCE, FRENCH POLYNESIA, GERMANY, HONG KONG, HUNGARY, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAPAN, KAZAKHSTAN, KOREA, KUWAIT, LEBANON, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, NORWAY, OMAN, POLAND, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TUNISIA, T UREY, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, UZBEKISTAN, and VENEZUELA.
GE Healthcare Discovery MR450, Discovery MR750, Optima MR450w, Optima MR450w equipped with the GEM option, Discovery MR750w, and Discovery MR750w equipped with the GEM option products.   Affected devices are whole body magnetic resonance scanners indicated for use as a diagnostic imaging devices.
GE Healthcare has recently become aware of a potential safety issue with certain GE MRI Products.  Patient egress from the system can be delayed or impeded if the cradle release handle and/or cradle release block mechanism malfunctions or becomes misaligned. This could make the safe removal of the patient from the system difficult.
University Of Miami Miller School of Medicine Tissue Bank
Human bone allografts, mislabeled with an extended expiration date, were distributed.