Enforcement Report - Week of August 8, 2012
-
| Product Type | Recalling Firm | Classification | Status | Distribution Pattern | Event Details |
|---|---|---|---|---|---|
| Devices | Advanced Sterilization Products | Class II | Ongoing | Worldwide Distribution - USA (nationwide) | Details |
| Biologics | New York Blood Center, Inc. | Class III | Terminated | NY | Details |
| Biologics | Northern California Community Blood Bank | Class II | Terminated | CA, NJ, OH, TN | Details |
| Biologics | American National Red Cross (The) | Class II | Terminated | CA | Details |
| Biologics | Central Kentucky Blood Center, Inc. | Class III | Terminated | KY | Details |
| Biologics | American National Red Cross (The) | Class III | Terminated | CA | Details |
| Biologics | ZLB Bioplasma, Inc. | Class II | Terminated | Illinois | Details |
| Biologics | San Antonio Eye Bank | Class II | Terminated | CA, Saudi Arabia | Details |
| Food/Cosmetics | Cafe Moto | Class II | Ongoing | All direct consignees located within the state of CA. | Details |
| Biologics | Heartland Lions Eye Bank | Class II | Terminated | Corneas were distributed to Jordan Eye Bank, Jordan University Hospital, Queen Rania Street, Amman, Jordan | Details |
| Food/Cosmetics | Nestle USA | Class III | Terminated | Distributed to distributor and retail in US State of TX. | Details |
| Biologics | Delta Blood Bank | Class II | Terminated | CA. | Details |
| Biologics | Memorial Blood Centers | Class II | Terminated | MN | Details |
| Biologics | Bacterin International Inc. Biologics Division | Class III | Ongoing | Distributed nationwide | Details |
| Biologics | Memorial Blood Centers | Class II | Terminated | NC, NJ, MN, WI, OH, CA, MI. | Details |
| Devices | Church & Dwight Inc | Class II | Ongoing | Worldwide Distribution. | Details |
| Biologics | Metro Blood Services | Class III | Terminated | New Jersey | Details |
| Biologics | Seattle Sperm Bank LLC | Class II | Ongoing | Approximately two thirds of product went to Denmark, Australia, Canada, and Mexico. The remaining one third distributed domestically nationwide. | Details |
| Drugs | Eagle Pharmaceuticals Inc. | Class I | Ongoing | New Jersey | Details |
| Biologics | Haemonetics Corporation | Class III | Terminated | Nationwide | Details |
| Devices | Smiths Medical ASD, Inc. | Class I | Ongoing | Worldwide Distribution -- USA, including the state of CA, and country of Canada. | Details |
| Biologics | International Sight Restoration, Inc. | Class II | Terminated | Cario, Egypt | Details |
| Food/Cosmetics | Defense Nutrition | Class III | Ongoing | Distribution was made to IL, MI, MS, AL, CO, MD, TX, GA, NY, KS, AR, FL, NV, WA, CT, UT, VT, PA, LA, TN, NE, MN and OR. Foriegn distribution was made to Canada. | Details |
| Veterinary | Hartz Mountain Corp. | Class I | Ongoing | Nationwide | Details |
| Devices | Integra LifeSciences Corp. | Class II | Ongoing | Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IN, KS, KY, LA, MA, MD, MI, MN, MO, NC, NE, NH, NM, NJ, NY, NV, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA & WI and internationally to Belgium; Danemark; France; Germany; Israël; Italy; Lebanon; Luxemburg; Netherlands; Norway; Portugal; Saudi Arabia; Spain; Switzerland; Turkey & United Kingdom. | Details |
| Veterinary | Central Garden & Pet Company | Class I | Ongoing | Nationwide including Puerto Rico. OUS to include: Abu Dhabi, Argentina, Australia, Brazil, Brunei, Canada, China, Costa Rica, Czechoslovakia, Dominican Republic, Dutch Antilles, Finland, Germany, Great Britain, Greece, Guam, Honduras, Hong Kong, Ireland, Israel, Japan, Korea, Kuwait, Mexico, New Zealand, Pakistan, Panama, Russia, Singapore, South Africa, Sweden, Thailand, and Trinidad. | Details |
| Devices | Zimmer Inc. | Class II | Ongoing | Worldwide Distribution - USA (nationwide) and the countries of Singapore, China, Hong Kong,Canada, Australia, Japan, Europe, Germany, India, and Finland. | Details |
| Biologics | Arc Blood Services, New England Region | Class II | Terminated | Connecticut; California | Details |
| Biologics | American Red Cross Blood Services | Class III | Terminated | Connecticut; New York | Details |
| Biologics | Central California Blood Center | Class II | Terminated | Ohio; Maryland; California; New York | Details |
| Biologics | Blood Assurance Inc | Class II,Class III | Terminated | Tennessee; Indiana | Details |
| Biologics | LifeServe Blood Center | Class II | Terminated | Iowa | Details |
| Veterinary | Wellpet Llc | Class I | Ongoing | Nationwide Canada | Details |
| Biologics | Gulf Coast Regional Blood Center | Class II | Terminated | Texas | Details |
| Biologics | Immucor Inc | Class III | Ongoing | US/Nationwide; Canada, China, Denmark, India, Israel, Japan, Philippines, & Sweden | Details |
| Biologics | Biomat USA, Inc. | Class III | Terminated | California | Details |
| Drugs | Mallinckrodt Inc. | Class II,Class III | Ongoing | Nationwide | Details |
| Biologics | SCC Soft Computer | Class II | Ongoing | New York and Michigan | Details |
| Biologics | Plasmacare Inc | Class III | Terminated | California | Details |
| Biologics | Plasmacare Inc | Class III | Terminated | California | Details |
| Biologics | Plasmacare Inc | Class III | Terminated | California | Details |
| Biologics | Plasmacare Inc | Class III | Terminated | California | Details |
| Biologics | Plasmacare Inc | Class III | Terminated | California | Details |
| Biologics | Plasmacare Inc | Class III | Terminated | California | Details |
| Biologics | Plasmacare Inc | Class III | Terminated | California | Details |
| Biologics | Plasmacare Inc | Class III | Terminated | California | Details |
| Biologics | Plasmacare Inc | Class III | Terminated | California | Details |
| Biologics | Plasmacare Inc | Class III | Terminated | California | Details |
| Biologics | Plasmacare Inc | Class III | Terminated | California | Details |
| Biologics | Plasmacare Inc | Class II,Class III | Terminated | California | Details |
| Biologics | Plasmacare Inc | Class III | Terminated | California | Details |
| Biologics | Plasmacare Inc | Class III | Terminated | California | Details |
| Biologics | Plasmacare Inc | Class III | Terminated | California | Details |
| Biologics | Plasmacare Inc | Class III | Terminated | California | Details |
| Biologics | Plasmacare Inc | Class III | Terminated | California | Details |
| Biologics | Plasmacare Inc | Class III | Terminated | California | Details |
| Devices | Abbott Point Of Care Inc. | Class II | Completed | USA ( nationwide ) | Details |
| Food/Cosmetics | J F C International Inc | Class II | Ongoing | Nationwide in the US | Details |
| Drugs | Watson Laboratories Inc | Class III | Ongoing | Nationwide. | Details |
| Drugs | VistaPharm, Inc. | Class II | Ongoing | Nationwide | Details |
| Biologics | LifeSouth Community Blood Centers Inc - Birmingham Region | Class II | Terminated | Alabama | Details |
| Biologics | LifeSouth Community Blood Centers Inc - Birmingham Region | Class II | Terminated | Alabama | Details |
| Biologics | LifeSouth Community Blood Centers, Inc. | Class II | Terminated | Florida | Details |
| Biologics | LifeShare Blood Centers | Class II | Terminated | Texas | Details |
| Biologics | Blood Systems Inc/dba United Blood Services | Class II | Terminated | Mississippi; Alabama | Details |
| Devices | GE OEC Medical Systems, Inc | Class II | Terminated | Worldwide Distribution - US (nationwide) and the countries of: Canada, France, Japan, and China. | Details |
| Food/Cosmetics | Itoen (USA) Inc | Class III | Ongoing | Product was released for distribution in HI. | Details |
| Devices | Sunrise Medical (US) LLC | Class II | Ongoing | Worldwide Distribution - US (nationwide) and the countries of Argentina, Brazil, Columbia, Costa Rica, Mexico, Panama, Uruguay and Venezuela. | Details |
| Food/Cosmetics | Andante Dairy | Class II | Ongoing | CA, OH and NY to retail stores and restaurants. | Details |
| Biologics | Sunquest Information Systems, Inc. | Class III | Terminated | Nationwide | Details |
| Devices | Stryker Instruments Div. of Stryker Corporation | Class II | Ongoing | Worldwide Distribution - US Nationwide and the countries of England, France, Netherlands, and Switzerland. | Details |
| Devices | Perkinelmer | Class II | Ongoing | Worldwide Distribution - US (nationwide) and the countries of Australia, Belgium, Brazil, Egypt, France, Germany, Netherlands, Norway, Saudi Arabia,Switzerland, | Details |
| Devices | Beekley Corporation | Class II | Ongoing | US Nationwide Distribution | Details |
| Devices | Baxter Healthcare Renal Div | Class II | Ongoing | Nationwide Distribution includingArizona, California, Ohio, Pennsylvania and Virginia. | Details |
| Devices | ICU Medical, Inc. | Class II | Completed | Nationwide distribution | Details |
| Devices | Intuitive Surgical, Inc. | Class II | Ongoing | Worldwide Distribution - US Nationwide and the countries of: Australia, Spain, India, Italy and Saudi Arabia. | Details |
| Devices | Iris Diagnostics | Class III | Ongoing | Nationwide Distribution | Details |
| Food/Cosmetics | Winn Dixie Stores, Inc. | Class II | Completed | Florida, Georgia, Alabama, Mississippi, Louisiana | Details |
| Devices | Exactech, Inc. | Class II | Ongoing | Worldwide Distribution - USA including FL, MO, MA, AL, KY, IN, NC, LA,PA, VA, OH, NY, ME, MI, TX, KS, TN, OK, NJ, WA, CO, GA, CA, MN, IA, OR, and IL and Internationaly to Austria, Luxenbourg, Sweden, Germany, Spain, France, Greece, Italy, Nederland, United Kingdom, Canada, India, Australia, Switzerland, and Sao Palo. | Details |
| Drugs | Apotex Inc. | Class II | Ongoing | Nationwide and Puerto Rico | Details |
| Devices | Maquet Medical Systems, Usa | Class II | Ongoing | Worldwide Distribution - USA (nationwide) and the countries of United Arab Emirates, Austria, Australia, Belgium, Brazil, Canada, Switzerland, China, Germany, Denmark, Spain, France, Hong Kong, Ireland, Israel, India, Italy, Japan, South Korea, Netherlands, Poland, Russia, Saudi Arabia, Sweden, Singapore, and Thailand. | Details |
| Drugs | Dr. Reddy's Laboratories, Inc. | Class II | Ongoing | Nationwide and Puerto Rico | Details |
| Drugs | Zydus Pharmaceuticals USA Inc | Class II | Ongoing | Nationwide | Details |
| Food/Cosmetics | The Wright Group dba Wright Enrichment, Inc. | Class I | Ongoing | IN | Details |
| Food/Cosmetics | Spillson's, Ltd. | Class I,Class II | Ongoing | Retail stores, truck stops, Vending facilities in the Monroe Michigan Area. | Details |
| Devices | Aesculap Implant Systems LLC | Class II | Ongoing | US Nationwide Distribution - including the states of CO, OH, OK and TX. | Details |
| Drugs | West-ward Pharmaceutical Corp. | Class II | Ongoing | All lots were distributed throughout the US. | Details |
| Drugs | Axcentria Pharmaceuticals LLC | Class III | Ongoing | Michigan | Details |
| Drugs | Cadence Pharmaceuticals | Class II | Ongoing | Nationwide | Details |
| Drugs | Bayer HealthCare Pharmaceuticals Inc. | Class II | Ongoing | Kansas and California. | Details |
| Food/Cosmetics | CHETAK SAN FRANCISCO LLC. | Class I | Ongoing | Northern CA only | Details |
-
