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U.S. Department of Health and Human Services

Enforcement Report - Week of January 23, 2013

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Product Type Recalling Firm Classification Status Distribution Pattern Event Details
Biologics Penrose-St Franc Health Services Blood Bank Class III Terminated CO Details
Biologics ARC Blood Services, New England Region Class II,Class III Terminated CA, MA, ME, NH, NY Details
Biologics American National Red Cross (The) Class II Terminated PA Details
Biologics LifeServe Blood Center Class II Terminated South Dakota, Austria Details
Biologics LifeServe Blood Center Class II Terminated IA, SD Details
Biologics American Red Cross Blood Services Class II Terminated MO Details
Biologics American Red Cross Blood Services Class II Terminated Missouri Details
Biologics LifeServe Blood Center Class II Terminated New York Details
Biologics Baylor University Medical Center - Transfusion Service Center Class II Terminated TX Details
Biologics American National Red Cross (The) Class II,Class III Terminated PA, CO and CA Details
Biologics University of Texas Medical Branch at Galveston (The) Class II Terminated TX Details
Biologics Community Blood Center Of Gtr KC Class II Terminated Missouri Details
Biologics Community Blood Center Of Gtr KC Class II Terminated Kansas Details
Biologics American National Red Cross Class II,Class III Terminated Washington, Oregon, and California. Details
Biologics Community Blood Center Of Gtr KC Class II Terminated Missouri Details
Biologics American National Red Cross Class II Terminated Maryland. Details
Biologics BioLife Plasma Services LP Class III Terminated CA Details
Biologics American National Red Cross Class II Terminated California. Details
Biologics American Red Cross Blood Services Class II,Class III Terminated Missouri; Texas Details
Biologics American National Red Cross Class II Terminated Oregon and California. Details
Biologics American Red Cross Blood Services Class II,Class III Terminated Tennessee; Missouri Details
Biologics Interstate Blood Bank Inc Mo Class II Terminated Austria Details
Biologics American National Red Cross (The) Class II,Class III Terminated Maryland and California Details
Biologics American National Red Cross Class II Terminated Oregon. Details
Biologics American National Red Cross (The) Class II Terminated Oregon. Details
Biologics American Red Cross Blood Services Class II,Class III Terminated Missouri; California Details
Biologics American National Red Cross (The) Class II,Class III Terminated Massachusetts and California. Details
Drugs Teva Pharmaceuticals USA, Inc. Class III Ongoing Nationwide Details
Drugs James G. Cole, Inc. Class II Ongoing Product was distributed nationwide and Canada Details
Devices DePuy Spine, Inc. Class II Ongoing Worldwide Distribution - USA (nationwide) and internationally to Belgium, Egypt, Ireland, Italy, Portugal, and the UK. Details
Veterinary Breeders Choice Pet Foods Inc Class I Ongoing U.S. states to include California, Georgia, Illinois, Nevada, Ohio, Virginia, and Washington. Details
Devices Vycor Medical, Inc. Class I Ongoing Worldwide Distribution - USA (Nationwide) in the states of TX, IL, NJ, FL, OH, PA and (International) in the country of Japan. Details
Devices Philips Medical Systems (Cleveland) Inc Class II Ongoing Worldwide Distribution-USA including the states of AZ, CA, CO, IL, IL, IN, MA, ME, MI, MO, NC, NJ, NY, OR, TN, TX, VA and WI and the countries of Austria, Canada, China, France, India, Ireland, Italy, Japan, Netherlands, Norway, Spain, Switzerland, Thailand and United Kingdom. Details
Biologics LifeShare Blood Centers Class II Terminated Louisiana Details
Veterinary Del Monte Corp Class I Ongoing Products were distributed nationwide. Details
Veterinary Wildwood Seeds Class I Ongoing Products are distributed in Oregon and Washington Details
Veterinary HBD International Class I Terminated OR Details
Veterinary Wixon, Inc. Class I Ongoing CA, IL, GA, NJ, CT, KS, MN, MA, WA, ME, NY. Details
Food Frito Lay, Inc Class I Ongoing Nationwide Details
Devices Bausch and Lomb, Incorporated Class I Ongoing Worldwide distribution: USA including DC and PR; and countries of: Canada and Mexico accounts not available at this time. Details
Devices Fresenius Medical Care Holdings, Inc. Class III Ongoing US Nationwide Distribution Details
Devices Perkinelmer Class II Ongoing Nationwide Distribution. Details
Devices Philips Medical Systems (Cleveland) Inc Class II Ongoing Worldwide distribution: USA including IN, OH and OR; and the countries: Australia, Belgium, China, Israel, and Sweden. Details
Food Sugar Flowers Plus Class I Ongoing Nationwide. Details
Food Fresh Unlimited Inc Class I,Class II Ongoing Product was shipped to the folloiwng states: AL, FL, GA, IL, IN, KY, MI, NC, NY, OH, PA, TN, VA, WI & WV. Details
Food Unilever United States, Inc. Class II Ongoing Nationwide Details
Devices Stryker Howmedica Osteonics Corp. Class II Ongoing Nationwide Distribution, including the states of PA, OH, NY, CA and IL. Details
Veterinary Hospira Inc. Class II Ongoing Alabama, Colorado, District of Columbia, Florida, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Minnesota, Missouri, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas and Virginia. Details
Food Ocean Beauty Seafoods, LLC Class I Ongoing Nationwide to distributors and retailers in AZ, CA, CO, CT, MA, NH, NJ, NY, OR, PA, RI, TX and WA. Details
Devices Spacelabs Healthcare, Llc Class II Ongoing Worldwide Distribution-USA including Puerto Rico and the states of California, Florida, Iowa, Illinois, Louisiana, Michigan, Minnesota, North Carolina, South Carolina, Texas, and Washington, and the countries of Argentina, Mexico, France, and India. Details
Food Naturally Fresh Inc. Class II Ongoing U.S. Details
Food Cap Sur Mer, Inc. Class I Ongoing Portsmouth, NH; Raynham, MA; Taunton, MA Details
Drugs Boehringer Ingelheim Roxane Inc Class III Ongoing Nationwide Details
Drugs L. Perrigo Co. Class II Ongoing Nationwide Details
Food Dollar Tree Distribution, Inc. Class II Ongoing Nationwide and Canada Details
Food Local Baking, Co, Inc. T/A Joey's Fine Foods Class II Ongoing New York and New Jersey Details
Devices Terumo Cardiovascular Systems Corporation Class II Ongoing Nationwide and worldwide: AL , AR , AZ , CA , CO , CT , FL , GA , HI , IA , IL , IN , KS , KY , LA , MA , ME , MI, MO , NC , ND , NV , NY , OH , OK , PA , SD , TN , TX , UT , VA , WA , and WI. Bahrain, BRAZIL, CANADA, CHILE, Honduras, Singapore, Taiwan, Trinidad and Tobago, and UNITED ARAB EMIRATES (UAE). Details
Food S & M International Inc Class II Ongoing NY, MI, PA, KY, West Virginia Details
Food Somersault Snack Co., LLC Class I Ongoing Nationwide and Canada Details
Devices Quanta System, S.p.A. Class II Ongoing Class II Recall - Worldwide Distribution - USA including TX, AZ, OR, and CO. Only US product is affected by this recall. Details
Food Woodstock Farms Class I Ongoing Alabama, Connecticut, Florida, Georgia, Illinois, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, New Hampshire, New Jersey, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Vermont, Virginia, Wisconsin, and District of Columbia Details
Drugs Upsher Smith Laboratories, Inc. Class III Ongoing Nationwide and Puerto Rico Details
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