Safety Alerts & Recalls

Search all Safety Alerts & Recalls

Latest Alerts

McNeil Recalls Single Lot of Tylenol 8 Hour Extended Release Caplet - 150 count
McNeil Consumer Healthcare is recalling one product lot of Tylenol 8 Hour Extended Release Caplets 150 count bottles distributed in the United States. McNeil is issuing the recall because their surveillance and monitoring efforts identified a small number of complaints of a musty or moldy odor. The odor is thought to be caused by the presence of trace amounts of chemicals called 2,4,6-tribromoanisole (TBA) and 2,4,6-trichloroanisole (TCA). This voluntary recall is being taken as a precaution and the risk of adverse medical events is very low. The product was manufactured at the McNeil Consumer Healthcare plant in Fort Washington, PA prior to the company's voluntary closure of the plant in April 2010. The recall is for Tylenol 8 Hour Extended Release Caplets 150 count bottles, lot number ADM074. The lot number can be found on the side of the bottle label. For more information, please visit: http://www.mcneilproductrecall.com/page.jhtml?id=/include/news_march_2011.inc
Learn More

APP Pharmaceuticals, Inc. Recalls Select Lots of Irinotecan Vials Due to Contamination
APP Pharmaceuticals, Inc., (APP) has issued a voluntary recall of five lots of Irinotecan Hydrochloride Injection, which is used for recurrent or progressive metastatic cancer of the colon or rectum. APP decided to take this action due to several customer complaints about a potential contaminant in the product solution in lot 870DE00301. This recall is being conducted as a precautionary measure. Contamination of products administered via the intravenous route has the potential to cause infections, especially in patients who are having chemotherapy. APP is not aware of any adverse patient events resulting from this product and is continuing its investigation of the situation. The five recalled lots include: Irinotecan Hydrochloride Injection, 100mg/5mL, (20mg/mL), 5mL Single Dose Vial - Lots 870DE00101, 870DE00201, 870DE0030, and 870DE00401 Irinotecan Hydrochloride Injection, 40mg/2mL, (20mg/mL), 2mL Single Dose Vial - Lot 870CZ00301 For more information, please visit: http://www.fda.gov/Safety/Recalls/ucm248576.htm
Learn More

Date Published Title Drug Source
2011-03-31 McNeil Recalls Single Lot of Tylenol 8 Hour Extended Release Caplet - 150 count Acetaminophen Manufacturer
2011-03-30 APP Pharmaceuticals, Inc. Recalls Select Lots of Irinotecan Vials Due to Contamination Irinotecan FDA
2011-03-30 FDA Issues Safety Alert: Special Storage and Handling Requirements Must Be Followed for Pradaxa (Dabigatran Etexilate Mesylate) Capsules Dabigatran FDA
2011-03-28 Possible Label Switch Prompts Recall of Generic Citalopram 10mg and Finasteride 5mg Citalopram FDA
2011-03-24 FDA Issues Update for Proton Pump Inhibitors and Risk of Fractures Dexlansoprazole FDA
2011-03-18 Lilly Informs Customers of Important Information About Alcohol Prep Pads in Forteo Starter Kits Teriparatide Manufacturer
2011-03-17 Primatene Mist With Chlorofluorocarbons No Longer Available After Dec. 31, 2011 Epinephrine FDA
2011-03-14 King Pharmaceuticals Inc. Recalls Embeda Morphine and Naltrexone Manufacturer
2011-03-10 New Study: Mothers Taking Opioid Pain Medicines May Place Infants At Increased Risk for Birth Defects MediGuard CRT
2011-03-08 Animas Insulin Pump 2.0 mL Cartridge Recalled Insulin Manufacturer
2011-03-08 FDA Warns About Serious Health Problems Seen in Premature Babies Given Kaletra Oral Solution Lopinavir with Ritonavir FDA
2011-03-05 Marlex Pharmaceuticals and Cispharma Inc. Recall Select Lots of Acetaminophen Tablets, 325mg Acetaminophen FDA
2011-03-05 Glenmark Generics Inc. Recalls Several Lots of Alclometasone Dipropionate Ointment USP, 0.05% Alclometasone FDA
2011-03-05 Teva Pharmaceuticals Recalls Several Lots of Nifediac CC (nifedipine), Extended Release Tablets, 30 mg, 60 mg and 90 mg Nifedipine FDA
2011-03-05 FDA Warns About Risk of Oral Birth Defects in Children Born to Mothers Taking Topiramate Topiramate FDA
2011-03-02 FDA Warns: Low Magnesium Levels Can Be Associated With Long-Term Use of Prescription Proton Pump Inhibitors Dexlansoprazole FDA
2011-03-01 FDA Review of Abacavir Finds No Increased Risk of Heart Attack Abacavir with Lamivudine FDA
2011-03-01 Nycomed Recalls Single Lot of Fluticasone Propionate Ointment, 0.005% Fluticasone Topical FDA
2011-03-01 Nycomed Recalls Single Lot of Fluticasone Propionate Ointment, 0.005% Fluticasone FDA
2011-02-25 Recall of Certain Lots of SUDAFED 24 Hour Pseudoephedrine Manufacturer
Back to Consumer Med Safety