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U.S. Department of Health and Human Services

Enforcement Report - Week of March 6, 2013

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Product Type Recalling Firm Classification Status Distribution Pattern Event Details
Biologics American Red Cross Blood Services Class II Terminated IL Details
Biologics American Red Cross Blood Services Class II,Class III Terminated MO, TX, CA Details
Biologics Mississippi Valley Reg Bld Ctr Class II Terminated Switzerland. Details
Biologics Mississippi Valley Reg Bld Ctr Class II Terminated Iowa Details
Biologics Mississippi Valley Reg Bld Ctr Class II Terminated Iowa Details
Biologics Siouxland Community Blood Bank Class II Terminated IA, Austria Details
Biologics American National Red Cross (The) Class II Terminated Utah, Maryland, California. Details
Biologics LifeSouth Community Blood Centers, Inc. Class II Terminated Georgia Details
Biologics American Red Cross Blood Services Class II Terminated Missouri Details
Biologics American Red Cross Blood Services Class II Terminated Missouri Details
Biologics American Red Cross Blood Services Class II Terminated Missouri Details
Biologics American National Red Cross Class II,Class III Terminated California. Details
Biologics Puget Sound Blood Center and Program Class II Terminated California. Details
Biologics Puget Sound Blood Center and Program Class II Terminated Austria. Details
Biologics Puget Sound Blood Center and Program Class II Terminated Washington. Details
Biologics American National Red Cross (The) Class II Terminated IL Details
Biologics American National Red Cross (The) Class II,Class III Terminated IL, NJ, Details
Food Giannios Candy Co Inc Class I Completed The product was distributed in the states of OH, PA, MI, NY. Details
Biologics Talecris Plasma Resources Inc Class III Terminated North Carolina Details
Biologics CSL Plasma, Inc. Class II Terminated Illinois, Switzerland, and Germany, Details
Biologics American National Red Cross (The) Class II Terminated Oregon, Washington, Arizona, Virginia, and Alabama. Details
Biologics Plasma Biological Services Class II Terminated NC Details
Biologics BioLife Plasma Services L.P. Class II Terminated CA Details
Devices Advanced Neuromodulation Systems Inc. Class II Ongoing Worldwide Distribution - 53 consignees out of the US. Details
Biologics Genzyme Corporation Class II Ongoing Nationwide Details
Devices Orthofix, Inc Class II Ongoing Worldwide Distribution - USA (nationwide) Internationally to Australia, Hong Kong, Saudi Arabia, Korea, Turkey, Greece, Finland, South Africa, Spain, Singapore, Switzerland, Brazil, Germany, France, Japan, Netherlands, New Zealand, Israel, Canada and Mexico. Details
Drugs Dr. Reddy's Laboratories, Inc. Class II Ongoing Nationwide Details
Devices Philips Medical Systems (Cleveland) Inc Class II Ongoing Worldwide Distribution - USA ( nationwide) including the states of AK, AL, AR, AZ, CA, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, TN, TX, VA, WA, WV and WY, and the countries of Albania, Algeria, Argentina, Australia, Austria, Belarus, Belgium, Bolivia, Brazil, Canada, China, Colombia, Denmark, Dominican Republic, Ecuador, Egypt, France, Germany, Ghana, Gibraltar, Greece, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Libyan Arab Jamahiriya, Lithuania, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Turkey, Turkmenistan, United Arab Emirates, United Kingdom, Venezuela, Viet Nam & Yemen. Details
Devices Philips Healthcare Inc. Class II Ongoing Worldwide Distribution - USA Nationwide and the Foreign countries of: Austria, Canada, Belgium, China,Denmark, France, germany, Italy, Netherlands,New Zealand, Norway, Philippines, Portugual, SOuth Korea, Spain, Switzerland, Thailand, and UK. Details
Biologics Blood Bank Of Delmarva, Inc Class II,Class III Terminated Ohio; Indiana Details
Biologics HCSC-Blood Center Class II Terminated Pennsylvania Details
Biologics Interstate Blood Bank, Inc. of Wisconsin Class II Terminated California; Germany, Details
Biologics Upstate New York Transplant Services Class II Terminated New York Details
Biologics Suncoast Communities Blood Bank, Inc. Class II Terminated Florida Details
Biologics Carter BloodCare Class II Terminated Austria; Texas Details
Biologics Community Blood Center Class III Terminated Ohio Details
Biologics New York Blood Center, Inc. Class II Terminated New York Details
Drugs Bayer Healthcare, LLC Class III Ongoing Nationwide Details
Devices Philips Medical Systems (Cleveland) Inc Class II Ongoing Worldwide Distribution - USA including AK, AK, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, OA MA, MD MI, MN, MO, MS, NC, D, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV; Internationally to Canada and other countries.. Details
Food Productos 2001 Inc. Class II Completed PR Only (retailers at the north side of the Island) Details
Drugs Amedra Pharmaceuticals LLC Class II Ongoing Nationwide and Puerto Rico. Details
Devices Intel-GE Care Innovations LLC Class II Terminated Nationwide Distribution. Details
Veterinary ADM Alliance Nutrition, Inc. Class III Ongoing IN and OH Only Details
Drugs Hospira, Inc. Class II Ongoing Nationwide Details
Food Homestead Creamery Class I Ongoing The product was distributed to stores in MO and an open farmer's market in gift baskets. Exact dates of the start of distribution are not clear. The plastic packaging film used to package the recalled product is supplied by: Specialty Foods, Roland Park, KS. The Annato cheese food coloring, cheese cultures and Rennet are supplied by, Dairy Connections, Madison, WI. Details
Drugs West-ward Pharmaceutical Corp. Class II Ongoing GA Details
Drugs West-ward Pharmaceutical Corp. Class II Ongoing Nationwide Details
Devices GE Healthcare, LLC Class II Ongoing Nationwide Distribution Details
Cosmetics Procter & Gamble Hair Care Llc Class III Ongoing Distribution was made to AR, AZ, AK, CA, CO, IA, IL, IN, KS, MI, MO, MN, NC, NE, NV, OR, TX, UT and WI. Details
Drugs Pacira Pharmaceuticals, Inc. Class II Ongoing Nationwide distribution: AZ, DC, FL, GA, MA, NJ, NY, OH, and TX. Details
Food Whole Foods Market Class I Ongoing Arkansas, California, Colorado, Connecticut, Florida, Idaho, Kansas, Louisiana, Maine, Massachusetts, Nevada , New Jersey, New Mexico, New York, Oklahoma, Rhode Island, Texas and Utah. Details
Food Giant Greens, Inc. Class I,Class II Ongoing Products distributed in Alaska, Idaho, Oregon, Washington, and British Columbia, Canada. Details
Biologics Lions Eye Institute for Transplant & Research, Inc. Class II Terminated Indonesia; Egypt; Mexico; Saudi Arabia; Florida; Missouri; New Jersey; Dominican Republic Details
Biologics American Red Cross Blood Services Heart of America Region Class II Terminated Illinois, Oklahoma Details
Devices Elekta, Inc. Class II Ongoing Nationwide Distribution including TX Details
Devices GE Healthcare, LLC Class II Ongoing Nationwide Distribution including NM, WY, FL, MO, MA, and MI. Details
Devices Cellestis Inc Class II Ongoing Worldwide distribution: USA (nationwide) and countries of: Argentina, Australia, Austria, Belgium, Bosnia and Herzegovina, Bulgaria, Czech Republic, Denmark, Estonia, Finland, France, Germany, Great Britain, Ireland, Israel, Jordan, Luxembourg, Mexico, Netherlands, New Zealand, Peru, Poland, Saudi Arabia, Slovakia, Slovenia, South Africa, Switzerland, and Turkey. Details
Devices Medical Components, Inc dba MedComp Class II Ongoing USA Nationwide Distribution including the state of PA. Details
Food Aptalis Pharma Us Inc Class II Ongoing Nationwide, Italy, Canada, and Brazil Details
Devices Baylis Medical Company Inc. Class II Ongoing International distribution to the country of Australia. Details
Devices Orthofix, Inc Class II Ongoing Worldwidewide Distribution - USA Nationwide including Puerto Rico and the countries of: Australia, Lebanon, Germany, Spain, Sweden and Israel. Details
Biologics Indiana Lions Eye and Tissue Transplant Bank Class II Terminated Saudi Arabia; Indiana Details
Food GoldCoast Salads Class I Ongoing AL, FL, GA, MA, MD, NC, NJ, NY, PA, TN and VA Details
Devices Medacta Usa Inc Class II Terminated Nationwide Distribution including the states of ID, CO, TX, WI, NY, CT, WA, CA, UT, and AZ. Details
Devices Ultradent Products, Inc. Class III Ongoing USA Nationwide Distribution including the states of CA, AZ, CO and WA. Details
Devices Stryker Spine Class II Ongoing Nationwide Distribution including the states of AL, AZ, CA, CO, FL, GA, IA, IL,IN, KS, LA, MA, MD, MI, MO, MN, NC, NY. OH, OK, OR, PA, TN, TX, UT and WI. Details
Devices Oculus Innovative Sciences Inc Class II Ongoing "Nationwide Distribution - One distributor in PA " Details
Drugs Actavis Pharmaceuticals Class III Ongoing Nationwide Details
Devices Mc-NEIL-PPC, Inc. Class II Ongoing Nationwide Distribution. Details
Food Specialty Commodities, Inc. Class I Ongoing CA, IL, MO, ND, NJ, OK, PA, WI Details
Food Zip International Group Class I Ongoing NY Details
Food Qtrade Teas And Herb Class I Ongoing Nationwide in the US: CA, NY, PA, NJ, MO, MA, OH, RI, CO, NC. Worldwide in: Canada Details
Food Whole Foods Market Class III Ongoing Nationwide domestically and to Canada. Details
Devices Integra LifeSciences Corp. Class II Ongoing Worldwide Distribution - USA Nationwide including Canada. Details
Food Teatulia Class I Ongoing Shipped to one distributor who sold it to 15 restaurants all in Colorado. Details
Food Js Pelmeni Ok, Inc. Class I Ongoing New York, Massachusetts, Pennsylvania, New Jersey, and Illinois. Details
Food Associated Milk Producers, Inc Class I Ongoing One distributor in WI Details
Food Muffin Mam Inc (The) Class I Ongoing GA, NC, SC, PA, TN, VA and WV. Details
Food Koda Farms Inc Class II Ongoing CA and HI Details
Devices Philips Medical Systems (Cleveland) Inc Class II Ongoing Worldwide Distribution - USA including AL, AR, CA, FL, GA, IL, IN, KY, MI, MS, NC, NJ, NV, NY, OH, PA, PR and VA. Details
Devices Philips Medical Systems (Cleveland) Inc Class II Ongoing Distributed only in Ohio. Details
Devices Aesculap, Inc. Class II Ongoing USA Nationwide Distribution including the states of: AR, CA, FL, IN, IA, KS, MD, MN, MO, OR, TN, TX, VA and WA. Details
Devices Myco Medical Supplies Inc Class II Ongoing Worldwide Distribution - USA including CA, FL, IL, MI, MO, NY, OH, PA, SC, TN, WI and Internationally to Canada Details
Drugs Hospira Inc. Class II Ongoing Nationwide Details
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