McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc. (McNeil), is voluntarily recalling, at the wholesale and retail levels, seven lots, approximately 574,000 bottles, of Infants TYLENOL Oral Suspension, 1 oz. Grape distributed nationwide in the United States (see full product list below). Infants TYLENOL is an over-the-counter (OTC) product indicated as a pain reliever/fever reducer.
Category Archives: Food & Drug Recalls
FDA approves Zioptan to treat elevated eye pressure
On February 10, the U.S. Food and Drug Administration approved Zioptan (tafluprost ophthalmic solution) to help reduce elevated eye pressure in people with open-angle glaucoma.
Flight Medical Innovations Ltd. Provides Update on Recall of Ventilator Remote Alarm Cable
Flight Medical Innovations Ltd. (Flight Medical) issued the following update regarding its voluntary recall of remote alarm cable, part number V24-00400-29, used to connect a Newport HT50 mechanical ventilator to a nurse station. The recalled cable may negatively affect Newport HT50 ventilators manufactured prior to 2007.
FDA seeks $4.5 billion to support medical product development, protect patients and ensure safety of the food supply
The U.S. Food and Drug Administration is requesting a budget of $4.5 billion to protect and promote the public health as part of the President’s fiscal year (FY) 2013 budget – a 17 percent increase over the FDA enacted budget for FY 2012. Industry user fees would fund 98 percent of the proposed budget increase. The FY 2013 request covers the period from Oct. 1, 2012 through Sept 30, 2013.
New Jersey company agrees to halt production of unapproved dental devices
Accurate Set Inc., of Newark, N.J., and the company’s president and owner, Cornell L. Adams, have agreed to stop manufacturing and distributing medical devices as part of a consent decree of permanent injunction.
Walmart Recalls Cruller Bakery Pastries Due To Mislabeled Milk Allergen
Walmart recalled its eight-count packages of Cruller bakery pastries because the common name of milk was not listed following sodium caseinate, a milk derivative, on the ingredient label. People who have milk allergies that do not recognize sodium caseinate as a milk derivative run the risk of serious or life-threatening allergic reactions if they consume the product.
Whole Foods Market Recalls Pumpkin Bundt Cakes For Undeclared Allergens
Whole Foods Market is recalling its 3 ounce and 26 ounce Pumpkin Bundt Cakes because the products contain undeclared milk. No illnesses have been reported to date, however people who have allergies to milk, run the risk of serious or life-threatening allergic reaction if they consume these products.
Regeneca, Inc. Issues A Voluntary Nationwide Recall Of A Specific Lot Of RegenArouse Because Of Potential Health Risks
Regeneca, Inc. announced today that it is conducting a voluntary nationwide recall of RegenArouse, Lot Number 130100, because FDA lab analysis has confirmed the presence of Tadalafil making these products unapproved new drugs. Tadalafil is an FDA-approved drug used as treatment for male Erectile Dysfunction (ED). The active drug ingredient is not listed on the label for these products.
FDA investigating illegal online sale of handheld dental X-ray units
The U.S Food and Drug Administration is warning dental and veterinary professionals to not purchase or use certain potentially unsafe hand-held dental X-ray units. The FDA is concerned that these devices may not be safe or effective and could expose the user and the patient to unnecessary and potentially harmful X-rays. The units, sold online by manufacturers outside the United States and directly shipped to U.S. customers, have not been reviewed by the FDA and do not meet FDA radiation safety requirements. (MB)
Summit Import Corporation Issues Allergy Alert on Undeclared Eggs in Bin Bin Snow Rice Cracker 5.3oz Pack and Bin Bin Rice Cracker 15.8oz Bulk Pack
Summit Import Corp., at 100 Summit Place, Jersey City, New Jersey, is
recalling Bin Bin Snow Rice Cracker 5.3oz Pack and Bin Bin Rice Cracker
15.8oz Bulk Pack because the affected products contain egg which are not
declared on the label. Consumers who are allergic to eggs may run the risk of
serious or life-threatening allergic reactions if they consume this product.