Archive for June, 2011

Valproate Products: Drug Safety Communicaton – Risk of Impaired Cognitive Development in Children Exposed In Utero (During Pregnancy)

Benefits and risks of valproate sodium and related products should be carefully weighed when prescribing these drugs to women of childbearing age.

Tags:

FDA: New York dietary supplement manufacturer enters into consent decree

The U.S. Food and Drug Administration has announced that Howard Sousa, doing business as the Artery Health Institute LLC, and DeSousa LLC, in New York, N.Y., has signed a consent decree of permanent injunction. The consent decree prohibits Sousa from distributing products with claims in the labeling to cure, treat, mitigate or prevent diseases.

Tags:

Tylenol Extra Strength Caplets, 225 count bottles: Recall – Uncharacteristic Odor

One lot recalled due to the presence of trace amounts of a 2,4,6-tribromoanisole (TBA), which has been associated with temporary and non-serious gastrointestinal symptoms.

Tags:

Featured

McNeil Consumer Healthcare Announces Voluntary Recall Oe One Product Lot Of TYLENO® Extra Strength Caplets 225 Count Distributed In The U.S.

Fort Washington, PA – McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc., is recalling at the retail level one product lot (60,912 bottles) of TYLENOL®, Extra Strength Caplets, 225 count bottles, distributed in the U.S. The recalled product was manufactured in February, 2009. McNeil is taking this action following a small number of odor reports, including musty, moldy odor. The uncharacteristic musty, moldy odor has been linked to the presence of trace amounts of a chemical known as 2,4,6-tribromoanisole (TBA).

Tags:

Risvold’s Salads Inc ISSUES ALLERGY ALERT ON UNDECLARED allergens in Seafood Salad and Seafood Pasta Salad

Risvold’s Salads Inc of Gardena, CA is recalling seafood salad and seafood pasta salad, because it may contain undeclared milk, sunflower, sesame and soy. People who have an allergy or severe sensitivity to milk, sunflower, sesame and soy run the risk of serious or life-threatening allergic reaction if they consume these products.

Tags:

Safe Use Initiative: Preventing Harm from Medicines

Studies suggest that up to 50 percent of the harm from medications is preventable. Learn how FDA is collaborating with others to prevent medication errors, misuse, and abuse.

Tags:

FDA’s MedWatch Safety Alerts: May 2011

FDA warns consumers about birth control pills that may increase the risk of blood clots; Avandia and other diabetes medicines, which carry new restrictions; dietary supplements packaged to look like antibiotics; a recalled blood thinner; and more.

Tags:

Nestlé Purina Recalls Limited Number of Dry Cat Food Bags Due to a Potential Health Risk (Shipped Only to Colorado, Idaho and Oregon)

Nestlé Purina PetCare Company (NPPC) is voluntarily recalling approximately 870 bags of dry cat food shipped to Colorado, Idaho and Oregon. This is being done as a precautionary measure, as the product has the potential to be contaminated with Salmonella.

Tags:

Featured

JFC International Inc. Issues Allergy Alert Due To Undeclared Milk Protein in UCC and Taitan Instant Drink Mix Products

JFC International, Inc. of Los Angeles, CA is recalling all UCC and Taitan Instant Drink Mix because they contain undeclared milk protein. People who have an allergy or severe sensitivity to milk may run the risk of serious or life-threatening allergic reactions if they consume these products.

Tags:

Nature Relief Instant Wart and Mole Remover: Recall – Risk of Severe Skin Burns

Active ingredient calcium oxide can cause severe burns, particularly to areas of thin or sensitive skin such as the face, around the eyes, and genitalia.

Tags: