In a June 19, 2013 press release, Advance Pharmaceutical Inc., through the Food and Drug Administration (FDA), announced a voluntary nationwide recall of their over-the-counter low dose aspirin. The recall is in response to a complaint that a bottle of the product labeled as Enteric Coated Aspirin Tablets, 81 mg, actually contained Acetaminophen 500 tablets.
The recalled aspirin is packaged in bottles of 120 tablets with product numbers NDC 0536-3086-41 and UPC 3 0536-3086-41 9, Lot 13A026 with Expiration Date 01-2015.
According to the press release, directions on the recalled aspirin say patients should take 4-8 tablets every 4 hours, but not more than 48 tablets in 24 hours. Patients who take 48 tablets daily of the recalled product could be ingesting as much as 24,000 mg of Acetaminophen, which is about six times the maximum recommended daily dose of acetaminophen (4,000 mg). Acetaminophen may cause liver damage to people who take other drugs containing acetaminophen, people who drink three or more alcoholic beverages per day, and people who have liver disease. The aspirin was made and packaged by Advance Pharmaceutical and distributed nationwide by Rugby Laboratories.
Advance Pharmaceutical is calling for the return of all recalled bottles. Consumers who have the product with the affected lot number and expiration date should stop using it and return it to the pharmacy or store where they bought it.
Consumers with questions can contact Advance Pharmaceutical Inc., Monday-Friday, 9 am- 5 pm EST. Consumers should notify their physician or healthcare provider if they have any problems that may be related to taking or using this product.
Consumers experiencing adverse reactions from using this product should be reported to the FDA’s MedWatch Program either by Fax at 1-800-FDA-0178, by regular mail at MedWatch Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, or online at http://www.fda.gov/MedWatch/report.htm2.
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