U.S. Including: CA, IL, LA, OH, PA, and SC.
METOCLOPRAMIDE ORAL SOLUTION, USP 10 mg/10 mL, 10 mL cups, Rx only. Manufactured by VistaPharm, Inc, Largo, FL. NDC: 66689-031-01.
Defective Container: Lids on unit dose cups are not fully qualified.
Nationwide Distribution -- AK, AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, MA, MD, MI, MN, MT, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TX, UT, VA, VT, WA, and WI.
Philips GoSafe Mobile Help Button; 7000MHB.   Personal Emergency Response System.
Irregular battery disconnection resulted in issues with Mobile Health Button (MHB) Charging.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Florida and via Internet sales nationwide, United Kingdom and Australia via internet by a 3rd party
A Thousands Virgins Grey Wash System (tattoo ink) sold in kits: Grey color shades G1, G2, and G3, 2 oz and 4 oz bottles.
Between 40 to 53 kits (some of product was stolen)
Microbial contamination of tattoo ink.  Contaminated with Mycobacterium chelonae, Microbacterium organisms, and molds Cryptococcus albidus and members of the Penicillium genus.
Harvest Slaw Kit, product ID 028-07114, package in bulk case, Net wt. 5.75 lbs. (2.61 kg).  UPC 0 45009 07114 9.   The product is labeled in parts ''***T/H HARVEST SLAW KIT***Ingredients: Brussels Sprouts, Turnips, Carrots, Sunflower Seeds (sunflower kernels, roasted in vegetable oil (sunflower), salt), Dried Currants, Green Onions, Red Bell Peppers, Parsley***KEEP REFRIGERATED***Net Wt: 5.75 lb (2.61 kg)***''.
Lot TFNW216, USE BY: 08/10/2015.   (TFNW represents Taylor Farms Northwest; 216 represents Julienne Date).
Undeclared peanuts.  Peanuts were inadvertently added to  salad kits instead of sunflower seeds and labels do not declare peanuts.
Broccoli Salad Kit, product ID; 028-07092, packaged in a bulk case, Net wt. 11 lbs (4.99 kg). UPC: 0 45009 07092 0   The product is labeled in parts ''***BROCCOLI SALAD KIT***Ingredients: Ingredients: Broccoli, Broccoli Slaw (broccoli, carrots, red cabbage), Coleslaw Dressing (high fructose corn syrup, soybean oil, water, sugar, tarragon flavored vinegar, distilled vinegar, egg yolks, salt, food starch-modified, xanthan gum, spice, sodium benzoate and potassium sorbate [as preservatives], paprika, eggs, spice, propylene glycol alginate, dehydrated onion, natural flavor, calcium disodium EDTA added to protect flavor, caramel color, turmeric), Red Onions, Raisins, Sunflower Seed Kernels (sunflower kernels, roasted in vegetable oil [sunflower], salt)***  CONTAINS: SOY, EGG***KEEP REFRIGERATED***Net Wt: 11 lb (4.99 kg)***''.
Lot TFNW216; USE BY: 08/14/2015.   (TFNW represents Taylor Farms Northwest; 216 represents Julienne Date).
Undeclared peanuts.  Peanuts were inadvertently added to  salad kits instead of sunflower seeds and label does not declare peanuts.
Worldwide Distribution - US (nationwide) and Internationally to AT, BE, CA, CN, CZ, DE, ES, FI, FR, GB, IT, KR, LT, LV, NL, NO, PE, PL, PT, RU, and ST.
PROFEMUR PLUS CoCr MODULAR NECK, REF: PHAC1254, SIZE LONG, ORIENTATION 8 degree VAR/VAL.   12/14 SLT Taper.   Orthopedic hip prosthesis component.
Unexpected rate of postoperative fractures resulting in the need for revision surgery.
Platelets Pooled Leukocytes Reduced Irradiated
Blood product, with a low platelet yield, was distributed.
The product was distributed to one consignee in Texas.  There was no foreign, government, nor military distribution.
CiCi's Cavatappi, Enriched Macaroni Product, packaged in 5-lb. bags, 4 bags per case, Packed exclusively for use by CiCi's Pizza and its Franchisees, JMC Restaurant Distribution, LP, Coppell, TX.
Lot number 063015V, exp. June 30, 2017; and lot number 070115V, exp. July 1, 2017.
Undeclared egg.  Egg containing-macaroni was inadvertently mixed with macaroni that did not contain egg.
American Red Cross Blood Services Appalachian Region
Blood and Blood Products for Reprocessing
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
Blood Systems, Inc. dba United Blood Services Texas
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Worldwide Distribution - US Nationwide in the states of: CO, IA, IL, IN, KY, MD, MN, MO, NC, NJ, NY, OH, OK, OR, TX, VA, WA & WY and the countries of CANADA, AUSTRALIA, UNITED KINGDOM & NEW ZEALAND.
Ferno iNX Wheeled Stretcher, Integrated Patient Transport & Loading System   Product Usage:  Stretcher for pre-hospital patient transport.
The firm became aware of an instance of a hole elongation in the telescoping load frame channel. A hole elongation could affect the ability of the retention pin to stay seated which is necessary to preclude movement of the telescoping load frame.
US Distribution to states of: AL, AR, CA, IL, IN, MS, OH, OK & TN.
Histolock Resection Device, US endoscopy. An electrosurgical device designed to be used to endoscopically grasp, dissect and transect tissue during gastrointestinal endoscopic procedures.
The company has determined the sterility cannot be assured for the affected lot.
Hartley Medical Center Pharmacy, Incorporated
Prolotherapy with Phenol (Dextrose 25%, Glycerin 10%, Lidocaine HCl 10%, Bupivacaine HCl 0.625%, Phenol 1%, QS SWI), 5 mL vial, Rx Only, Hartley Medical, (888) 671-2888
Non-Sterility: Hartley Medical Center Pharmacy, Inc. is recalling Prolotherapy with Phenol due to non-sterility concerns.
Prolotherapy with Phenol (Dextrose 25%, Glycerin 25%, Phenol 2.5%, QS SWI), 100 mL vial, Rx Only, Hartley Medical, (888) 671-2888
Mixed Fruit Candy, Net Wt. 12 oz. (340g), Distributed by: Prosperity Resources Int'l, Inc., Product of China, UPC 6 47406 02091 3
Prosperity Resources is recalling Sun Kee Mixed Fruit Candy because sampling analysis revealed it contains undeclared colors, FD&C Blue #1, Red #40, Yellow #5 and #6 and the product also contains an unallowable dye: 16185 - Amaranth (E123) - delisted FD&C Red #2
Blood product, in which quality control and distribution of product  did not meet specifications, was distributed.
US Nationwide Distribution in the states of CA, KY, MI, OH, UT and  WI.
Zimmer, Reprocessed Zimmer Tourniquet Cuffs,34'' Single Hose Single Bladder Brown (PLC), 34'',  Model (Reprocessor) Number: ZIM60-7075-106, Reprocessed by Sterilmed.   Products are individually packaged in a Tyvek/poly pouch. There are 5 pouches placed inside a casepack box. Each sales unit (casepack) contains 5 devices.
Sterilmed, Inc. is recalling its reprocessed Zimmer Tourniquet Cuff, Part #ZIM60-7075-106, lot number 1846885 due to mislabeling. The affected reprocessed product is labeled as single hose devices but the devices inside the packaging are dual hose devices.
EVIS EXERA II  Gastrovideoscope OLYMPUS GF type UCT180; designed for endoscopic real-time ultrasound imaging, ultrasound guided needle aspiration and other endoscopic procedures within the upper gastrointestinal tract and surrounding organs.
Insufficient information for specific cleaning accessories used for the cleaning and reprocessing of the GF-UCT180 ultrasound endoscope
Domestic: FL, WA, SC   Foreign: None  VA/DOD: None
Mouth Care Kit containing Biotene Toothpaste
Centurion Medical Products initiated a voluntary recall on 07/31/2015 of specific lots of their mouth care convenience kits due to a supplier recall of the Biotene Toothpaste for possible wood fragments.
ONCOLOGY ORAL CARE KIT containing Biotene Toothpaste
Centurion Code: BTP75, Material Number: MC535, Batch #. s 2014121590 & Exp. 03/2017.
Nationwide to 34 states.  No foreign/VA/govt/military.
KAL Brand Amino Acid Complex UPC 021245 51610 1, Product #51610
UPC 021245516101, Product #51610, All lots with Use By Dates prior to January 2019.
Undeclared allergen, casein is a disclosed ingredient, but the word milk not specifically noted on the ingredient list
Connecticut, Delaware, Maryland, New Jersey, New York, and Pennsylvania.
America's Choice Straight  Cut Sweet Potatoes Fries, Frozen 539 g in plastic bag. Distributed by: ONPOINT Inc. Montvale, NJ. Product of Canada  UPC: 7 54807 12025 5
Arrow Kits with Medtronic Covidien'' 0.9% Sodium Chloride Flush Syringes
Manufacturer of 0.9% Sodium Chloride Flush Syringes recalled due to compromised sterility of the outer barrel, Arrow purchased recalled items that were packaged with certain products. No patient injuries have been reported.
Nationwide to retail dipping stores, retirement communities, and one distributor: FL, GA, AL, TX, SC, RI, MI
Caramel Caribou Ice Cream, 3 gal, frozen in bulk round container.
U.S. Nationwide including Puerto Rico and Guam; Canada.
Rodan & Fields Proactiv Solution, Sheer Finish Compact Foundation, salicylic acid acne treatment, FAIR, 7 g/0.25 OZ. Compacts, Over the Counter. Manufactured for Guthy-Renker  Palm Desert, CA 92250.
Subpotent Drug: Salicylic acid is subpotent.
Rodan & Fields Proactiv Solution, Sheer Finish Compact Foundation, salicylic acid acne treatment, LIGHT, 7 g/0.25 OZ. Compacts, Over the Counter. Manufactured for Guthy-Renker  Palm Desert, CA 92250.
Rodan & Fields Proactiv Solution, Sheer Finish Compact Foundation, salicylic acid acne treatment, MEDIUM, 7 g/0.25 OZ. Compacts, Over the Counter. Manufactured for Guthy-Renker  Palm Desert, CA 92250.
Rodan & Fields Proactiv Solution, Sheer Finish Compact Foundation, salicylic acid acne treatment, TAN, 7 g/0.25 OZ. Compacts, Over the Counter. Manufactured for Guthy-Renker  Palm Desert, CA 92250.
Rodan & Fields Proactiv Solution, Sheer Finish Compact Foundation, salicylic acid acne treatment, DARK, 7 g/0.25 OZ. Compacts, Over the Counter. Manufactured for Guthy-Renker  Palm Desert, CA 92250.
Hill Country Fare Natural Spring Water 1 GAL./3.78L container packaged in polyethylene jug
LIPO B STERILE INJECTION 10 mL ( Methionine 25 mg, Inositol 50 mg, Choline Chloride 50 mg, Pyridoxine Hydrochloride 5 mg, Methylcobalamin 0.1mg, Benzyl Alcohol, Sterile Water, Sodium Hydroxide, Hydrochloric Acid), Multidose vial,  Rx Only,  Compounded by Eagle Pharmacy, Birmingham, AL 35244
Subpotent Drug: trace amounts of methylcobalamin in compounded drug.
ASP-1020 LipoTower with Aspiration Pump.  Medical use.
There is potential risk of electrical shock if lead wires inside the device become detached and the ground connection fails.
ASP-1021 LipoTower with Aspiration Pump and Tumescent Pump. Medical use.
168,  ASP-1021 LipoTower with Aspiration Pump and Tumescent Pump
Distributed to Colorado and Utah.  No foreign/VA/govt/military.
Coquette's Gluten Free Spring Pack Cupcakes (4 pack), Oranges n' Cream & Strawberry Mint Lemonade.  coquettesbistro.com.  NET Wt. 9.67 OZ.  No expiration date on package, sold in ambient air at retail.
Lot #1001, no expiraton date on packages.
Labeling incorrect with conflicting information, state: Contains No Egg or Dairy, but then later states: Ingredients: Whole Milk and Eggs. Product does contain milk and eggs.
Verapamil Hydrochloride Extended-Release tablets, USP, 240 mg, 500-count bottles, Rx Only, Apotex Corp. Manufactured by Apotex Research Private Limited, Bangalore, Karnataka 560 099, India; Manufactured for: Apotex Corp., Weston, FL 33326. NDC 60505-2742-5.
Failed Dissolution Specification: One lot of product did not meet the first stage dissolution specification limits.
Blood product, which did not meet the acceptable product specifications, was distributed.
Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
Blood products, collected from a donor for whom donor suitability was not adequately determined, was distributed.
Worldwide Distribution - US (nationwide) including Puerto Rico and Virgin Islands., and to the countries of : Canada, Brazil, Algeria, Mexico, Austria, Taiwan, Belgium, Hong Kong, Croatia, Singapore, Denmark, Bahamas, Egypt, Panama, Finland, Dominican Republic, France, Guatemala, Germany, Australia, Ireland, Japan,Italy, Haiti, Jordan, Malaysia, Kenya, India, Lebanon, Luxembourg, Malta, Mauritius, Morocco, Netherlands, Norway, Poland, Portugal, Russia, Saudi Arabia, Serbia, South Africa, Spain, Sweden, Switzerland, United Kingdom and United Arab Emirates.
Zimmer Guide Wires for orthopedic procedures.
00-2228-024-00 2.4MM Diameter Bullet Tip Guide Wire; 00-2255-025-00 Humeral Smooth Guide Wire 2.4mm 70cm Length;  00-2255-026-00 Humeral Bullet Tip Guide Wire 2.4mm Diameter 70cm Length;  47-2237-033-00 Smooth Guide Wire 2.4mm Diameter 100cm Length;  47-2237-037-00 3.0MM Diameter Smooth Guide Wire 100cm Length;  47-2237-038-00 Bullet Tip Guide Wire 3.0mm Diameter 100cm Length;  47-2255-008-00 Ball Tip Guide Wire 2.4mm Diameter 70cm Length;  47-2255-008-01 Ball Tip Guide Wire 3.0mm Diameter 100cm Length  All non-expired, distributed lots with a 10 year expiration date on the label.
voluntary recall of guide wires labeled with a 10-year expiration date, as it was found through review of packaging shelf life testing that product labeling of these sterile guide wires (external carton label and patient record label) states a 10-year expiration date. Package testing supports a 5-year expiration date for these same guide wires.
All Products Intended to be Sterile, mediStat Pharmacy, 110 East Azalea Ave., Foley, AL 36535, 844*737*2550.  An Incomplete List of Recalled Products Includes 1) All Cyanacobalamin Products, 2) All Magnesium Chloride Products, 3) All Lipostat (MIC B12) Products, 4) All Trimix (Papaverine/ Aloprostadil/ Phentolamine) Products, 5) All Testosterone Products, 6) All Dexamethasone Products, 7) All Levocarnitine Products, 8) All Hydroxyprogesterone Caproate Products, 9) All Triamcinolone Products, 10) All Betamethasone Sodium Phosphate Products, 11) All Methylprednisolone Acetate Products.
All Lots Not Expired and Distributed Before 8/5/15.
Worldwide Distribution.  US nationwide, Italy, Canada, Japan, China, Singapore, Colombia, England, Russia, Spain, France, Germany, Finland, Ireland, Australia, Sweden, Hungary, India, Brazil, Slovenia, Netherlands, Mexico, and South Africa.
Carto 3 EP Navigation System. Electro physiology system which views of the electrical activity of the heart through real-time data on 3-D, color-coded cardiac maps.
Image disappeared from the cardiac ultrasound system when the CARTO 3 EP Navigation System needed restarting while the patient was experiencing pericardial effusion.  Affects the CARTOSOUND Module of the CARTO 3 EP Navigation System when used with the SOUNDSTAR eco 8F and 10F Diagnostic Ultrasound Catheters.   New precautions added.
SOUNDSTAR eco 8F and 10F Diagnostic Ultrasound Catheters.  For intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart.
Worldwide Distribution - US (nationwide) and Internationally to  Canada; United Emirates; Australia; Belgium; Switzerland; China; Germany; Denmark; Spain; Finland; France; Great Britain; Greece; India; Israel; Italy; Japan; Netherlands; New Zealand; Poland; Portugal; Sweden; Singapore; Thailand; SK; Turkey; and South Africa.
P/N: 9735023, DRIVER 9735023 SOLERA 5.5/6.0 MAS; P/N: 9735024, DRIVER 9735024 SOLERA 5.5/6.0 MAS CAN;  P/N: 9735025, DRIVER 9735025 SOLERA 5.5/6.0 RMAS; P/N: 9735026, DRIVER 9735026 SOLERA 5.5/6.0 RMAS CAN; P/N: 9735027,DRIVER 9735027 SOLERA 5.5/6.0 FAS/SAS.  The Medtronic Navigated Solera Screwdrivers are reusable devices that are designed for use in spine surgery to assist in the placement of screws during the surgery, using a Medtronic computer-assisted surgery system.
For this action, device lot numbers are not applicable.  The action covers all lots of products distributed between September 2010 and July 2015
This field correction is being performed to provide the users of the Medtronic Navigated Solera Screwdrivers with additional information regarding the specific use conditions that can increase the possibility of a screwdriver tip deforming or breaking during surgery.
P/N: 9734856, SCREWDRIVER, 9734856, SOLERA STD MAST; P/N: 9734857, SCREWDRIVER, 9734857, SOLERA RDN MAST; P/N:  9734279, SCREWDRIVER 9734279 SOLERA STANDARD; and P/N: 9734373, SCREWDRIVER 9734373 SOLERA REDUCTION. The Medtronic Navigated Solera Screwdrivers are reusable devices that are designed for use in spine surgery to assist in the placement of screws during the surgery, using a Medtronic computer-assisted surgery system.
Savannah-Imperial LP- Savannah Sugar Refinery
AL, AR, FL, GA, IA, IL, IN, KY, MO, NC, NY, OH, PA, SC, TN, TX and VA.
Imperial Sugar, Pure Granulated Sugar, Net wt. 50 lbs (22.6 kg), Distributed by Imperial-Savannah LP, Sugar Land, Texas 77478.
Item 120514W and 120156H (Pharmaceutical), Lot Code Date: S237F
Foreign matter (blue fiber) detected in product.
West Creek, Extra Fine Granulated Sugar, Net Wt. 25 lbs (11.3 kg), Distributed by Performance Food Group, Richmond, VA 23238.
Monarch, Granulated Sugar, Net Wt. 25 lbs and 50 lbs (22.88 kg), Distributed by US Foods, Inc., Rosemont, IL.
Clear Value Sugar, granulated, Net Wt. 4 lbs (1.81 kg), Distributed by Topco Associates LLC, 7711 Gross Point Road, Skokie, IL 60077.
PSST, Granulated Sugar, Net Wt. 4 lbs (1.81 kg), Distributed by Kroger Co., Cincinnati, OH 45202.
Dixie Crystals, Sugar  EFG, Net Weight 50 lbs and 2000 lbs., Imperial Sugar Company, Savannah, GA.
Item 120663W and 123878W, Lot Code Date: S237F.
Imperial  GMI, Non GMO  Linerless Sugar  EFG, Net Weight 2000 lbs., Imperial Sugar Company, Savannah, GA.
Laura Lynn, Pure Cane Sugar, Net Wt. 25 lbs (11.34 kg), Distributed by Ingles Markets, Inc., Asheville, NC 26816.