Safety Alerts & Recalls

Search all Safety Alerts & Recalls

Latest Alerts

FDA Warns Consumers About Counterfeit Alli
The U.S. Food and Drug Administration (FDA) is warning consumers about a counterfeit and potentially harmful version of Alli 60 mg capsules (120 count refill kit). Laboratory tests conducted by GlaxoSmithKline (GSK), the maker of the FDA approved Alli product, revealed that the counterfeit version did not contain orlistat, the active ingredient in its product. Instead, the counterfeit product contained the controlled substance sibutramine. Sibutramine is a drug that should not be used without physician oversight. Sibutramine can also interact in a harmful way with other medications that the consumer may be taking. Consumers began reporting suspected counterfeit Alli to GSK in early December 2009. GSK has determined that the counterfeit product has been sold over the internet. At this time, there is no evidence that the counterfeit Alli product has been sold through other channels, such as retail stores. Alli is an FDA approved over-the-counter weight-loss product that contains the active ingredient orlistat. Orlistat is also marketed under the name Xenical and is available by prescription. For pictures of the counterfeit Alli and for more information, please visit: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm197857.htm and http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm197862.htm
Learn More

Voluntary Recall of Certain Lots of McNeil Over-the-Counter Products
McNeil Consumer Healthcare is expanding its December 2009 recall of Tylenol Arthritis Pain Caplet bottles to include certain lots of over-the-counter Tylenol, Motrin, Benadryl, Rolaids, Simply Sleep, and St. Joseph products. The company is carrying out this recall because they have received several consumer reports of an unusual moldy, musty, or mildew-like odor that was associated with nausea, stomach pain, vomiting and diarrhea. These reported cases were temporary and non-serious. The uncharacteristic smell is caused by the presence of trace amounts of a chemical called 2,4,6-tribromoanisole. The source of 2,4,6-tribromoanisole is believed to be the breakdown of a chemical used to treat wooden pallets that transport and store packaging materials. The health effects of this compound have not been well studied. At this time, all of the consumer cases reported to McNeil were associated with Tylenol Arthritis Pain Caplet 100 count bottles with the distinctive red EZ-OPEN CAP. McNeil has now identified and recalled all product lots that it believes may have the potential to be affected, even if they have not been the subject of consumer complaints. McNeil has set up a website to help you determine if any McNeil products that you may have are part of this recall: http://www.mcneilproductrecall.com For more information, please visit: http://www.mcneilproductrecall.com/page.jhtml?id=/include/press.inc
Learn More

Date Published Title Drug Source
2010-01-18 FDA Warns Consumers About Counterfeit Alli Orlistat FDA
2010-01-15 Voluntary Recall of Certain Lots of McNeil Over-the-Counter Products Aspirin Manufacturer
2010-01-15 Voluntary Recall of Certain Lots of McNeil Over-the-Counter Products Rolaids Multi-Symptom Manufacturer
2010-01-15 Voluntary Recall of Certain Lots of McNeil Over-the-Counter Products Calcium Carbonate with Magnesium Hydroxide Manufacturer
2010-01-15 Voluntary Recall of Certain Lots of McNeil Over-the-Counter Products Diphenhydramine Manufacturer
2010-01-15 Voluntary Recall of Certain Lots of McNeil Over-the-Counter Products Acetaminophen with Diphenhydramine Hydrochloride Manufacturer
2010-01-15 Voluntary Recall of Certain Lots of McNeil Over-the-Counter Products Acetaminophen Manufacturer
2010-01-15 Updated Information on Monitoring of Rapamune (Sirolimus) Drug Levels Sirolimus FDA
2010-01-15 Follow-Up to the FDA Safety Review of Tiotropium (marketed as Spiriva Handihaler) Tiotropium FDA
2010-01-07 Recall of Several Lots of Milk of Magnesia Cherry Liquid 12 ounce Bottles FDA
2009-12-29 Voluntary Recall of All Lots of Tylenol Arthritis Pain Caplet 100 Count Bottles Acetaminophen Manufacturer
2009-12-23 Voluntary Recall of 4.7 million Doses of Medimmune H1N1 Nasal Spray Vaccine Influenza A (H1N1) Vaccine Manufacturer
2009-12-23 Follow-up to the FDA's Ongoing Safety Review of Ezetimibe/Simvastatin (marketed as Vytorin), Simvastatin (marketed as Zocor) and Ezetimibe (marketed as Zetia) Ezetimibe FDA
2009-12-23 Follow-up to the FDA's Ongoing Safety Review of Ezetimibe/Simvastatin (marketed as Vytorin), Simvastatin (marketed as Zocor) and Ezetimibe (marketed as Zetia) Ezetimibe with Simvastatin FDA
2009-12-21 Recall on Vicks DayQuil Cold & Flu Vicks Dayquil Manufacturer
2009-12-21 Recall on Vicks DayQuil Cold & Flu Manufacturer
2009-12-18 Recall of Several Lots of Yaz and Ocella Drospirenone with Ethinyl Estradiol FDA
2009-12-18 Recall of Several Lots of PREMPRO 0.3 mg/1.5 mg EZ-DIAL Dispensers Estrogens Conjugated with Medroxyprogesterone FDA
2009-12-16 Voluntary Recall of Certain Lots of Sanofi Pasteur H1N1 Pediatric (0.25 mL, for 6-35 month olds) Vaccine Influenza A (H1N1) Vaccine Manufacturer
2009-12-15 Recall on a Single Lot of Phentermine 37.5 mg Tablets Phentermine FDA
Back to Consumer Med Safety