Author Archive for Food and Drug Administration
FDA Approves New Vaccine to Prevent Rotavirus Gastroenteritis in Infants
Closed Published by Food and Drug Administration December 3rd, 2006 in Regulatory AffairsThe Food and Drug Administration (FDA) today announced the approval of RotaTeq, a live, oral, vaccine for use in preventing rotavirus gastroenteritis in infants.
Krisp-Pak Company, Inc. Voluntarily Recalls Fresh Cut Fruit Because of Possible Health Risk
Closed Published by Food and Drug Administration November 28th, 2006Krisp-Pak Company, Inc. of Norfolk, VA is voluntarily recalling all lots of Krisp-Pak Brand packaged fresh cut fruit with expiration dates on or before 11/30/06, because it has the potential to be contaminated with Listeria monocytogenes.
Golden Glen Creamery Issues Voluntary Recall on Eggnog
Closed Published by Food and Drug Administration November 24th, 2006The eggnog was bottled in quart-glass containers labeled Golden Glen Creamery with a pull date of “Nov. 28″ on the cap.
FDA Approves First Generic Ondansetron Injection
Closed Published by Food and Drug Administration November 22nd, 2006 in Regulatory AffairsOndansetron is indicated for the prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy (cancer therapy that causes vomiting) and prevention of postoperative nausea and vomiting.
Advanced Medical Optics Announces Voluntary Recall of 18 Lots of Complete MoisturePLUS Contact Lens Care Products Distributed and Sold in the U.S.
Closed Published by Food and Drug Administration November 21st, 2006Contact lens users who experience symptoms of an eye infection such as redness, pain, tearing, increased light sensitivity, blurry vision, discharge or swelling, should remove their lenses and consult their eye care provider immediately.
Rockline Announces Voluntary Product Withdrawal of Wet Wipes Products
Closed Published by Food and Drug Administration November 20th, 2006The voluntary withdrawal is a result of routine product testing that detected the presence of a micro-organism known as Burkholderia cepacia (B. cepacia).
Birds Eye Foods Is Voluntarily Recalling Frozen Cooked Winter Squash Due To Potential Contamination
Closed Published by Food and Drug Administration November 20th, 2006Birds Eye Foods is voluntarily recalling frozen Cooked Winter Squash packed in a 12-oz. carton, under certain store brands, and the Birds Eye brand, which have an eight digit code beginning with one of the following characters: “5CF,” “5JE” or “6JE,” because some of the products were tainted with ammonia.
Rio Vista, Ltd. Recalls Cantaloupes Nationwide Because of Possible Health Risk
Closed Published by Food and Drug Administration November 20th, 2006Approximately, 62,640 cartons of cantaloupes were distributed in the U.S. and a small quantity went to Canada from October 31 to November 6, 2006. The cantaloupes were distributed for sale in bulk in cardboard cartons containing from 6 to 15 cantaloupes to a carton.
FDA Approves Silicone Gel-Filled Breast Implants After In-Depth Evaluation
Closed Published by Food and Drug Administration November 17th, 2006 in Regulatory AffairsAfter rigorous scientific review, the U.S. Food and Drug Administration (FDA) today approved the marketing of silicone gel-filled breast implants made by two companies for breast reconstruction in women of all ages and breast augmentation in women ages 22 and older.
FDA Invites Input on Electronic Submission of Regulatory Information
Closed Published by Food and Drug Administration November 16th, 2006 in Regulatory AffairsThe Public Hearing will Focus on Transforming to an All-Electronic Environment
Wegmans Issues Recall on Wegmans Italian Classics Lemon and Caper Sauce
Closed Published by Food and Drug Administration November 16th, 2006Wegmans Food Markets, Inc. is voluntarily recalling 11 oz. jars of Wegmans Italian Classics Lemon and Caper Sauce with a use-by date of 11/05/07 because they may contain pieces of glass which could cause injury or a choking hazard.
Timco Worldwide Inc. Recalls Cantaloupe Because of Possible Health Risk
Closed Published by Food and Drug Administration November 16th, 2006Timco Worldwide Inc. of Woodland, CA is voluntarily recalling its Sundia brand cantaloupe, because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
The Hershey Company Recalls Seven Bottles of Reese’s Shell Topping Due To Possible Health Risk
Closed Published by Food and Drug Administration November 15th, 2006The 7 (seven), 7.25 ounce bottles of REESE’S Shell Topping have the code 30MXB printed on the back of the bottle below the cap. The UPC/Bar Code is 346010.
FDA’s Dr. Boris Lushniak Receives AMA Award
Closed Published by Food and Drug Administration November 14th, 2006 in Regulatory AffairsThe AMA award citation praised Dr. Lushniak’s performance as a leader of the Department of Health and Human Services’ (HHS) Team San Antonio following last year’s hurricanes in the Gulf, including his “leadership to address public health issues following Hurricane Katrina, assisting more than 12,000 Katrina evacuees.”
FDA’s Dr. Boris Lushniak Receives AMA Award
Closed Published by Food and Drug Administration November 14th, 2006 in Regulatory AffairsThe AMA award citation praised Dr. Lushniak’s performance as a leader of the Department of Health and Human Services’ (HHS) Team San Antonio following last year’s hurricanes in the Gulf, including his “leadership to address public health issues following Hurricane Katrina, assisting more than 12,000 Katrina evacuees.”
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