FDA

Seattle's Favorite Gourmet Cookies and Dessert Co Issues Nationwide Allergy Alert on Undeclared Milk in Muffin Tops (November 14)

FDA Recalls - Sat, 2008-11-15 09:56
Seattle's Favorite Gourmet Cookies and Dessert Co. is recalling Orange Cranberry and Banana Nut Muffin Tops because they contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life threatening allergic reaction if they consume these products.
Categories: FDA

CSI USA, Inc. Issues Voluntary National Recall of Topical Acne Cream (November 13)

FDA Recalls - Thu, 2008-11-13 15:57
CSI, USA, Inc. issued a voluntary nationwide consumer product recall of all lots of 1 ounce (28 g) tubes of 10 Percent Benzoyl Peroxide Acne Cream with the following names: "DG Maximum Strength Acne Medicated Gel" (sold at Dollar General); "Kroger Acne Gel 10 Percent Benzoyl Peroxide Acne Medication" (sold at Kroger); and "Equate: Medicated Acne Gel" (sold at Wal-Mart).
Categories: FDA

FDA Warns Public of Extortion Scam by FDA Impersonators

FDA Press - Wed, 2008-11-12 17:36
The U.S. Food and Drug Administration is warning consumers about a fraudulent scheme to extort money from consumers by callers who falsely identify themselves as "FDA special agents" or other FDA officials.
Categories: FDA

Johnson and Johnson--Merck Consumer Pharmaceuticals Company Announces Urgent Voluntary Nationwide Recall Of Infants' Mylicon Gas Relief Dye Free Drops (Simethicone-Antigas) Non-Staining Due To Possible Metal Fragments (November 7)

FDA Recalls - Tue, 2008-11-11 21:52
Johnson and Johnson -- Merck Consumer Pharmaceuticals Company (JJMCP) is voluntarily recalling approximately 12,000 units of Infants' MYLICON GAS RELIEF DYE FREE drops (simethicone-antigas) non-staining sold in 1 oz. plastic bottles that were distributed after October 5, 2008 nationwide. The company is taking this action in consultation with the U.S. Food and Drug Administration (FDA). Although the potential for serious medical events is low, the company is implementing this recall to the consumer level as a precaution after determining that some bottles could include metal fragments that were generated during the manufacturing process. If any medical events were to occur, most are expected to be temporary and resolve without medical treatment. Parents who have given the product to their infant and are concerned should contact their health care provider immediately.
Categories: FDA

Nestle Withdraws Nestle Farinha Lactea Cereal in the United States (November 3)

FDA Recalls - Tue, 2008-11-11 21:52
Nestle is withdrawing Nestle Farinha Lactea cereal in the United States. Nestle is taking this action as we have learned that the product may contain residual traces of a pesticide not currently approved for use on wheat in the U.S. While the pesticide is approved for use in Brazil and the noted levels are well below Brazilian standards, it is not used on wheat products in the United States and therefore there is no set standard for its presence in cereal. The pesticide is permitted in the United States on grain crops other than wheat.
Categories: FDA

Amy's Kitchen Inc. Issues Allergy Alert and Voluntary National Recall due to Possible Undeclared Milk in Tofu Scramble in a Pocket Sandwich; Lot Code H148 (November 7)

FDA Recalls - Tue, 2008-11-11 21:42
The products could cause an allergic reaction if consumed by any individuals allergic to milk. People who have an allergy or severe sensitivity to dairy products run the risk of serious or life-threatening allergic reaction if they consume the product. Consumers without milk allergies can safely consume the product.
Categories: FDA

ETHEX Corporation Initiated Nationwide Voluntary Recalls of Specific Lots of Five Generic Products Due to the Potential for Oversized Tablets (November 7)

FDA Recalls - Mon, 2008-11-10 11:31
ETHEX Corporation announced that it has voluntarily recalled to the consumer level specific lots of five generic/non-branded products that it markets. These lots have been recalled as a precaution, due to the possibility that they may contain oversized tablets. Oversized tablets may contain more than the intended levels of the active drug ingredient, which could result in patients receiving as much as about twice the expected dosage of these drugs.
Categories: FDA

Nestle USA Voluntarily Recalls Two Production Codes of Nestle Nesquik Strawberry Powder (November 7)

FDA Recalls - Mon, 2008-11-10 10:55
The recall only includes two (2) production codes of 21.8-ounce containers of Nestle Nesquik Strawberry Powder. Printed on the bottom of each plastic container is a production code of "82255880" or "82265880" with a best by date of "August 2010."
Categories: FDA

FDA Seizes Contaminated Heparin from a Cincinnati Manufacturer

FDA Press - Thu, 2008-11-06 17:04
The five lots of Heparin Sodium Active Pharmaceutical Ingredient (API) and six lots of Heparin Lithium were seized at the FDA's request by U.S. Marshals. These products, which were manufactured from material imported from China, had been found by the agency to be contaminated with over-sulfated chondroitin sulfate (OSCS), a substance that mimics heparin's anticoagulant activity.
Categories: FDA

FDA Reports Nationwide Recall of Mislabeled ReliOn Insulin Syringes (November 5)

FDA Recalls - Wed, 2008-11-05 23:31
The U.S. Food and Drug Administration is notifying health care professionals and patients that Tyco Healthcare Group LP (Covidien) is recalling one lot of ReliOn sterile, single-use, disposable, hypodermic syringes with permanently affixed hypodermic needles due to possible mislabeling. The use of these syringes may lead to patients receiving an overdose of as much as 2.5 times the intended dose, which may lead to hypoglycemia, serious health consequences, and even death.
Categories: FDA

FDA Reports Nationwide Recall of Mislabeled ReliOn Insulin Syringes

FDA Press - Wed, 2008-11-05 23:31
The U.S. Food and Drug Administration is notifying health care professionals and patients that Tyco Healthcare Group LP (Covidien) is recalling one lot of ReliOn sterile, single-use, disposable, hypodermic syringes with permanently affixed hypodermic needles due to possible mislabeling. The use of these syringes may lead to patients receiving an overdose of as much as 2.5 times the intended dose, which may lead to hypoglycemia, serious health consequences, and even death.
Categories: FDA

General Mills Issues Voluntary Class One Recall Involving One Day's Production of Progresso Hearty Tomato Soup (October 31)

FDA Recalls - Mon, 2008-11-03 17:32
General Mills is voluntarily recalling a single day's production of Progresso Hearty Tomato soup because of a product labeling issue. Product produced on this date may have been mislabeled, and may contain allergens not listed on the ingredient label, specifically egg, milk, and soy.
Categories: FDA

Everlasting Distributors Inc. Issues a Nationwide Recall of Fresh and Crispy Jacobina Biscuits Because of Possible Health Risks (October 29)

FDA Recalls - Fri, 2008-10-31 20:33
Everlasting Distributors Inc., Bayonne NJ is initiating a nationwide recall of all their 3.88oz (110gm) packages of Fresh and Crispy Jacobina Biscuits because it may be contaminated with Melamine.
Categories: FDA

FDA Approves Toviaz, a New Drug to Treat Overactive Bladder

FDA Press - Fri, 2008-10-31 16:49
The U.S. Food and Drug Administration has approved a new drug to help patients suffering from overactive bladder (OAB). Toviaz (fesoterodine fumarate) works by relaxing the smooth muscle tissue of the bladder, thus reducing the urinary frequency, urge to urinate, and sudden urinary incontinence (leakage of urine), that are characteristic symptoms of OAB.
Categories: FDA

HHS/FDA Grants Tentative Approval for 75th Generic Anti-Retroviral Drug as Part of President's Emergency Plan for AIDS Relief

FDA Press - Wed, 2008-10-29 20:30
Marketed by Macleods Pharmaceuticals, Ltd, of Kachigam, Daman, in the Republic of India, the 75th drug is 150 milligram and 300 milligram tablets of generic lamivudine, a nucleoside analog reverse-transcriptase inhibitor (nRTI), which blocks an enzyme called reverse transcriptase, important to HIV production. HIV-infected patients who take lamivudine with other anti-HIV treatments develop less opportunistic infections.
Categories: FDA

FDA Statement on Release of Bisphenol A (BPA) Subcommittee Report

FDA Press - Tue, 2008-10-28 23:59
The subcommittee report to the Science Board raises important questions regarding the draft safety assessment, and the FDA looks forward to the review of the subcommittee's report by the Science Board on Oct 31.
Categories: FDA

FDA Issues Warning Letters to Bayer HealthCare for Illegally Marketing Two Unapproved Drugs

FDA Press - Tue, 2008-10-28 14:15
The U.S. Food and Drug Administration today sent Warning Letters to Bayer HealthCare concerning two unlawful, over-the-counter (OTC) aspirin products — Bayer Women's Low Dose Aspirin + Calcium (Bayer Women's) and Bayer Aspirin with Heart Advantage (Bayer Heart Advantage).
Categories: FDA

Mars Petcare US Issues Voluntary Recall of a Limited Number of Bags of SPECIAL KITTY Gourmet Sold at Wal-Mart locations in Fifteen States due to Potential Salmonella Contamination

FDA Recalls - Mon, 2008-10-27 23:46
Mars Petcare US today announced a voluntary recall of a limited number of bags of SPECIAL KITTY Gourmet Blend dry cat food sold at Wal-Mart locations in Connecticut, Delaware, Massachusetts, Maryland, Maine, North Carolina, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, Virginia, Vermont, and West Virginia. The pet food is being voluntarily recalled following a positive test result indicating a potential contamination with Salmonella.
Categories: FDA

Thoratec Corporation Issues Worldwide Medical Device Correction of HeartMate II Left Ventricular Assist System (October 24)

FDA Recalls - Sun, 2008-10-26 10:26
Thoratec Corporation is initiating a worldwide medical device correction of all serial numbers of the HeartMate II Left Ventricular Assist Systems (HM II LVAS) having Catalogue No. 1355 or 102139, which have been distributed since the beginning of clinical studies in November 2003. Over time, wear and fatigue of the percutaneous lead connecting the HeartMate II LVAS blood pump with the System Controller may result in damage that could interrupt pump function, require reoperation to replace the pump and potentially result in serious injury or death.
Categories: FDA

FDA Approves Lung Valve to Control Some Air Leaks after Surgery

FDA Press - Fri, 2008-10-24 19:57
The U.S. Food and Drug Administration today approved an implantable and removable valve system designed to control some air leaks in the lungs that persist after certain kinds of lung surgery.
Categories: FDA
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