Safety Alerts & Recalls

Search all Safety Alerts & Recalls

Latest Alerts

McNeil Expands Recall To Include Additional Lots of Benadryl Allergy Ultratab, Children's Tylenol Meltaways, Motrin, IB, Tylenol Extra Strength, and Tylenol PM
McNeil Consumer Healthcare is recalling 21 additional lots of over-the-counter medicines, including Benadryl Allergy Ultratab, Children's Tylenol Meltaways, Motrin, IB. Tylenol Extra Strength, and Tylenol PM. This recall is a follow-up to product recalls that McNeil Consumer Healthcare announced on January 15, 2010 and June 15, 2010. These three recalls are due to consumer complaints of a musty or moldy odor that has been linked to the presence of trace amounts of a chemical called 2,4,6-tribromoanisole (TBA). After a full investigation, it was determined that the source of TBA and odor was the result of a breakdown of a chemical that is applied to wood used to build wooden pallets that transport and store product packaging materials. Although consumers have reported stomach pain, diarrhea, and nausea with the recalled product, McNeil has determined that the risk of serious adverse medical events is very low. For more information and a list of the 21 recalled lots numbers, please visit: http://www.mcneilproductrecall.com/page.jhtml?id=/include/news_july.inc To view a complete list of products and lot numbers involved in all three recalls and to find out if a product you have has been recalled, please visit, www.mcneilproductrecall.com/page.jhtml?id=/include/prd_all.inc
Learn More

FDA Warns Using Malaria Medication for Leg Cramps Can Lead to Serious Side Effects
The U.S. Food and Drug Administration (FDA) today warned that the unapproved use of the malaria drug quinine sulfate to treat night time leg cramps has resulted in serious side effects. Quinine sulfate, commonly called just "quinine," is sold under the brand name Qualaquin. Qualaquin is FDA-approved only to treat a certain type of malaria (uncomplicated malaria). This infection, which is rare in the United States, is found mainly in travelers who have been to countries where malaria occurs. Most of Qualaquin's use in the U.S. is for the treatment or prevention of nighttime leg cramps, a use not approved by FDA. FDA has received reports of side effects after people used Qualaquin to prevent or treat leg cramps or restless leg syndrome. In some patients, these side effects resulted in permanent kidney damage and hospitalization. Two patients died. Most of those reporting serious side effects took the drug to prevent or treat leg cramps or restless leg syndrome. Reported side effects of Qualaquin include: serious bleeding due to a severe lowering of blood cells called platelets (thrombocytopenia); a condition that may result in permanent kidney damage; heart and blood vessel (cardiovascular) problems; hearing loss; and electrolyte imbalance. Because of these serious side effects, the manufacturer has developed a risk management plan for Qualaquin aimed at educating health care professionals and patients about the potential risks. For more information, please visit: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm217599.htm and http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm218383.htm
Learn More

Date Published Title Drug Source
2010-07-09 McNeil Expands Recall To Include Additional Lots of Benadryl Allergy Ultratab, Children's Tylenol Meltaways, Motrin, IB, Tylenol Extra Strength, and Tylenol PM Ibuprofen Manufacturer
2010-07-09 FDA Warns Using Malaria Medication for Leg Cramps Can Lead to Serious Side Effects Quinine Sulfate FDA
2010-07-06 Bristol-Myers Recalls Coumadin Blister Pack Samples Warfarin Manufacturer
2010-06-29 Two New Studies Suggest Diabetes Drug Avandia Increases Risk Of Heart Problems: FDA Safety Review Ongoing Glimepiride and Rosiglitazone MediGuard CRT
2010-06-25 P&G Recall: 4-Hour Nasal Decongestant Spray by Sinex Sold in U.S. Stores Oxymetazoline Manufacturer
2010-06-22 FDA: Pfizer Voluntarily Withdraws Mylotarg (gemtuzumab ozogamicin) From U.S. Market FDA
2010-06-18 Long-term Use of Isotretinoin Linked to Increased Risk of Ulcerative Colitis Isotretinoin MediGuard CRT
2010-06-18 FDA Warns That Generic Tamiflu From Internet Is Fake and Could Be Harmful Oseltamivir FDA
2010-06-16 McNeil Expands Recall To Include Benadryl Allergy Ultratab Tablets and Extra Strength Tylenol Rapid Release Gels Diphenhydramine Manufacturer
2010-06-15 FDA Warns Consumers About Correct Vitamin D Supplementation for Infants Ergocalciferol FDA
2010-06-14 Angiotensin-Receptor Blockers (ARBs) May Be Linked to Small Increased Risk of Cancer Telmisartan MediGuard CRT
2010-06-11 UCB Manufacturing, Inc and DSM Pharmaceuticals, Inc Recall Two Lots of Semprex-D Capsules Acrivastine and Pseudoephedrine FDA
2010-06-11 King Pharmaceuticals Inc, and Actavis Elizabeth LLC Recall Several Lots of Embeda Morphine and Naltrexone FDA
2010-06-11 Additional List of Recalled Lots of Daytrana Patches Published By FDA Methylphenidate FDA
2010-06-11 American Health Packaging and Rising Pharmaceuticals, Inc Recall Single Lot of Glycopyrrolate 2mg Tablets Glycopyrrolate FDA
2010-06-11 The U.S. Food and Drug Administration (FDA) Announces Ongoing Safety Review of Benicar and Risk of Heart Attack, Sudden Death, and Stroke Olmesartan and Hydrochlorothiazide FDA
2010-06-07 Recall of Several Lots of Acetasol HC and Hydrocortisone and Acetic Acid Ear Products FDA
2010-06-07 Generic Manufacturer Recalls Two Lots of Spironolactone 25 mg Tablets Spironolactone FDA
2010-06-07 CorePharma, LLC Recalls Select Lots of Glyburide and Metformin Tablets Glyburide with Metformin Hydrochloride FDA
2010-06-07 CorePharma, LLC Recalls Select Lots of Glipizide and Metformin Tablets Glipizide with Metformin FDA
Back to Consumer Med Safety