| 05/16/2013 |
Next by Nature |
Dark Chocolate Bananas |
Undeclared walnuts and milk |
Tropical Valley Foods Inc. |
 |
| 05/15/2013 |
Pentec Health |
In-date nutritional prescriptions for renal patients |
Lack of sterility assurance |
Pentec Health |
 |
| 05/15/2013 |
Rural King |
Deer Corn |
Aflatoxin |
Rural King Distributing |
 |
| 05/10/2013 |
Hospira |
Piperacillin and Tazobactam for Injection |
Precipitation/Crystallization in IV bag |
Apotex Corp. |
 |
| 05/10/2013 |
La Romanella |
Cheese Tortellini |
Undeclared wheat, eggs, and milk |
Smart & Final |
 |
| 05/10/2013 |
SexVoltz, Velextra, Amerect |
Dietary Supplements used as a sexual enhancement product |
Products may contain undeclared tadalafil |
BeaMonstar Products |
 |
| 05/10/2013 |
Symbios |
GoPump Rapid Recovery System kits and GOBlock kits |
Potential for excessively high flow rates |
Symbios Medical Products |
 |
| 05/09/2013 |
Whole Foods Market |
salads |
Undeclared egg and soy |
Whole Foods Market |
 |
| 05/09/2013 |
IGA |
Vanilla & Chocolate ice cream |
Undeclared almonds, coconut and soy |
Dairy Fresh |
 |
| 05/09/2013 |
Krinos |
Tahini Sesame Paste |
Salmonella |
Krinos Foods, LLC |
 |
| 05/07/2013 |
SexVoltz, Velextra, Amerect |
Dietary Supplements used as a sexual enhancement product |
Products may contain undeclared tadalafil |
BeaMonstar Products |
 |
| 05/07/2013 |
Lightning Rod |
Dietary supplements |
Contain an analogue of Sildenafil |
Chang Kwung Inc. |
 |
| 05/06/2013 |
Hannaford Supermarkets |
Cookies |
Undeclared nuts |
Hannaford Supermarkets |
 |
| 05/06/2013 |
The Compounding Shop LLC |
Compounded Products |
Concerns associated with quality control procedures that present potential risk to sterility assurance |
The Compounding Shop LLC |
 |
| 05/06/2013 |
Pure Herbs Ltd. |
Protein Extract |
Undeclared milk and soy |
Pure Herbs Ltd. |
 |
| 05/02/2013 |
California Pizza Kitchen, DiGiorno |
Pizza |
May contain fragments of clear plastic |
Nestle USA |
 |
| 05/02/2013 |
Bimeda & MWI |
Calcium Gluconate, Dextrose 50%, Hypertonic Saline |
Sterility of the products cannot be entirely assured |
Bimeda Inc. |
 |
| 05/02/2013 |
Medtronic |
Deep Brain Stimulation (DBS) lead kits |
Deep Brain Stimulation (DBS) lead damage |
Medtronic, Inc. |
 |
| 05/01/2013 |
XYMOGEN |
artriphen used as dietary supplement |
Undeclared milk and soy |
XYMOGEN |
 |
| 05/01/2013 |
Vicerex, Black Ant |
Dietary Supplement |
Undeclared Active Ingredients |
American Lifestyle |
 |
| 04/30/2013 |
Carson's |
Cookies |
Undeclared walnut, wheat, milk, peanut, soy |
Carson's Deli & Bakery |
 |
| 04/30/2013 |
Latis |
Herring |
Listeria monocytogenes |
Prime Food USA |
 |
| 04/29/2013 |
La Romanella |
Cheese Tortellini |
Undeclared wheat, eggs, and milk |
Smart & Final |
 |
| 04/29/2013 |
Krinos |
Tahini Sesame Paste |
Salmonella |
Krinos Foods, LLC |
 |
| 04/26/2013 |
Hospira |
Piperacillin and Tazobactam for Injection |
Precipitation/Crystallization in IV bag |
Apotex Corp. |
 |
| 04/26/2013 |
Hospira Inc. |
0.9% Sodium Chloride Injection, USP |
Particulates |
Hospira Inc. |
 |
| 04/26/2013 |
Maple View Farm |
Ice Cream |
Undeclared wheat, soy, almonds, and peanuts |
Maple View Farm |
 |
| 04/26/2013 |
Orville Redenbacher’s |
Classic Kettle Korn flavor ready-to-eat popcorn |
Undeclared milk |
ConAgra Foods, Inc. |
 |
| 04/24/2013 |
Cook Medical |
Zilver® PTX® Drug Eluting Peripheral Stent |
Delivery system tip separation |
Cook Medical |
 |
| 04/23/2013 |
7th Heaven Bakeries |
Oatmeal Raisin Cookies |
Undeclared Egg, Soy, and Milk |
7th Heaven Bakeries |
 |
| 04/23/2013 |
ebA |
Multivitamin Supplement |
Undeclared milk |
Saratoga Therapeutics, LLC |
 |
| 04/22/2013 |
Snap!, Cleo's, Jokerz and more |
Vegan Candy Bars |
Undeclared Milk |
Go Max Go Foods, LLC |
 |
| 04/22/2013 |
Nora Apothecary & Alternative Therapies |
All Sterile Compounded Drug Products within Expiration |
Lack of Sterility Assurance |
Nora Apothecary & Alternative Therapies |
 |
| 04/22/2013 |
Giraffe |
Giraffe Incubator with a Servo Control Oxygen System and Giraffe OmniBed |
After Powered On the oxygen set point or radiant heater set point may be overwritten. |
GE Healthcare |
 |
| 04/19/2013 |
California Natural, EVO, Healthwise, Innova, Karma. |
Pet Food |
Salmonella |
Natura Pet Products |
 |
| 04/18/2013 |
Newport |
Battery Pack |
Ventilators are alarming and going to internal backup battery sooner than expected while the ventilator is being operated on Power Pac battery. |
Covidien |
 |
| 04/18/2013 |
Vitae |
Bird food |
Salmonella |
Merit Bird Company, LLC |
 |
| 04/17/2013 |
Latis |
Herring and Salmon |
Listeria monocytogenes |
Prime Food USA |
 |
| 04/17/2013 |
Balanced Solutions Compounding Pharmacy |
Sterile drug products |
Lack of sterility assurance. |
Balanced Solutions Compounding Pharmacy, LLC |
 |
| 04/16/2013 |
Wegmans |
Roasted Red Pepper Dip |
Undeclared Eggs and Milk |
Wegmans Food Markets |
 |
| 04/15/2013 |
NuVision Pharmacy |
Lyophilized compounds HcG 5000IU-5ml and Sermorelin/GHRH6-5ml |
Lack of sterility assurance |
NuVision Pharmacy |
 |
| 04/15/2013 |
ApothéCure |
Sterile drug products |
Lack of sterility assurance |
ApothéCure Inc. |
 |
| 04/15/2013 |
O Organics |
Enchiladas |
Undeclared milk |
Cedarlane Natural Foods, Inc. |
 |
| 04/15/2013 |
InsuLinx |
Blood Glucose Meter |
lnsuLinx Meter will display and store in memory an incorrect test result that is 1024 mg/dL below the measured result. |
Abbott |
 |
| 04/12/2013 |
Chappaqua Crunch |
Simply Granola with Flax and Fruit (Gluten Free) |
Undeclared Almonds |
Wild Blue Yonder Foods |
 |
| 04/12/2013 |
Winn Dixie |
Apple Juice |
May contain elevated levels of patulin. |
Winn Dixie |
 |
| 04/10/2013 |
Affirm XL |
Dietary supplement |
Contain an analogue of sildenafil |
Affirm XL |
 |
| 04/10/2013 |
Showmaster® |
Lamb feed |
Contains incorrect sodium molybdate levels |
Cargill |
 |
| 04/10/2013 |
Stryker Corporation |
ShapeMatch Cutting Guides |
Due to the potential that ShapeMatch Cutting Guides may not have been manufactured in accordance with surgeon preoperative planning parameters or may have been manufactured outside of the planning ranges specified in the 510(k) clearance |
Stryker Corporation |
 |
| 04/05/2013 |
Green Valley Drugs |
Sterile, compounded products |
Lack of sterility assurance and concerns associated with the quality control processes |
Green Valley Drugs |
 |
| 04/04/2013 |
Little Mermaid Smoke House |
Smoked Herring and Pickled Herring fish |
Products were found to be uneviscerated, and have the potential to be contaminated with Clostridium botulinum |
Little Mermaid Smoke House |
 |
| 04/04/2013 |
Farm Rich, Market Day, Schwan's |
Mozzarella bites, quesadillas, pizza slices and more |
Escherichia coli O121 |
Rich Products Corporation |
 |
| 04/04/2013 |
Centerville Pie |
Clam Pies |
Undeclared fish (anchovies) |
Centerville Pie Company |
 |
| 04/03/2013 |
Bravo! |
Chicken Balance, Chicken Blend and Beef Blend Burgers - Raw Frozen Food Diet for Dogs and Cats |
Potential to be contaminated with Salmonella |
Bravo! |
 |
| 04/01/2013 |
ROCK-IT-MAN |
Male sexual enhancement capsules |
Product contains hydroxythiohomosildenafil, an analogue of sildenafil |
Consumer Concepts, Inc. |
 |
| 03/29/2013 |
California Natural, Evo, Health Wise, more |
Pet food |
Salmonella |
Natura Pet Products |
 |
| 03/29/2013 |
Hospira |
Sodium Chloride Injection |
Brass particulates |
Hospira, Inc. |
 |
| 03/28/2013 |
Heartland Gourmet |
Cookie mix, Pizza mix |
Undeclared milk |
Heartland Gourmet, LLC |
 |
| 03/28/2013 |
Farm Rich, Market Day |
Mozzarella Bites, Quesadillas, Pizza |
Escherichia coli O121 |
Rich Products Corporation |
 |
| 03/28/2013 |
NuGO |
Dessert Bars |
Undeclared milk |
Lifestyle Evolution, Inc. |
 |
| 03/27/2013 |
Buffalo Trace Distillery |
Marinade and Sauces |
Undeclared soy, anchovy, milk, and/or wheat |
Buffalo Trace Distillery |
 |
| 03/27/2013 |
Lisy |
Seasoning blends |
Undeclared soy |
Lisy Corporation |
 |
| 03/26/2013 |
Pallimed Solutions, Inc. |
Sterile compounded drugs |
Visible particulates |
Pallimed Solutions, Inc. |
 |
| 03/26/2013 |
La Preferida |
Canned Pinto beans |
Spoilage organisms or Pathogens |
La Preferida Inc. |
 |
| 03/26/2013 |
Publix Deli |
Fruit and Grain Salad |
Listeria monocytogenes |
Publix Super Markets |
 |
| 03/23/2013 |
Sweet P's Bake Shop |
Coffee Cake |
Undeclared walnuts |
Gold Standard Baking |
 |
| 03/20/2013 |
Med Prep Consulting, Inc. |
All compounded products |
Due To Potential Mold Contamination |
Med Prep Consulting, Inc. |
 |
| 03/20/2013 |
Clinical Specialties |
Acetylcysteine 10% solution, Cyclosporine 1% ophthalmic drops, Dexamethasone NaPo4 12 mg/ml, more |
Lack of sterility assurance |
Clinical Specialties Compounding Pharmacy |
 |
| 03/20/2013 |
New Chapter |
Dietary Supplement |
Undeclared Soy |
New Chapter, Inc. |
 |