DRUG RECALL - Enteric Coated Aspirin
June 17, 2013, Advance Pharmaceuticals issued a voluntary recall of Enteric Coated Aspirin, 81mg. This over-the-counter medication has been recalled due to a consumer complaint where the labeled bottle of Enteric Coated Aspirin, 81 mg, actually contained Acetaminophen 500 mg tablets. If the label directions are followed correctly, there is a possibility of acetaminophen overdose.
The affected lot is #13A026 with an expiry date of 01-2015.
Aspirin is used to treat mild to moderate pain, fevers, common cold, and headaches. Aspirin is used as an NSAID to reduce swelling, and to prevent blood clots to reduce the risk of stroke and heart attack.
Members using mail order should be aware that Benecard Central Fill did not dispense any of the affected lots.
If you have this product, it is suggested that you immediately cease its use and return any remaining medication to your pharmacy. If you have any questions about this recall please contact your local retail pharmacist or speak to your doctor.
Adverse events that may be related to the use of this product may also be reported to the United States Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting Program either online, by regular mail or by fax:
Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail the form to: MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787