June 20, 2013
Advance Pharmaceutical Inc. Issues Voluntary Recall of One Lot of Enteric Coated Aspirin Tablets
The Missouri Department of Health and Senior Services received information regarding a recall of Rugby label Enteric Coated Aspirin Tablets, 81 mg, Lot 13A026. The bottle labeled as Enteric Coated Aspirin Tablets, 81 mg, actually contains Acetaminophen 500 mg tablets.
The product is indicated for the temporary relief of minor aches and pains and is packaged in bottles of 120 tablet with NDC 0536-3086-41 and UPC 3 0536-3086-41 9, Lot 13A026 with Expiration Date 01-2015.
The lot was manufactured and packaged by Advance Pharmaceutical Inc. under the label of Rugby Laboratories. Rugby Laboratories (Major Pharmaceuticals) distributed the product nationwide to wholesalers and retailers.
Consumers may be inadvertently taking Acetaminophen 500 mg instead of Enteric Coated Aspirin 81 mg which may cause severe liver damage to those who take other drugs containing acetaminophen, consumers who take 3 or more alcoholic drinks every day, or those who have liver disease. The labeled directions instructs patients to take 4-8 tablets every 4 hours, but not more than 48 tablets in 24 hours. Consumers who take 48 tablets daily of the defective product may be ingesting up to 24,000 mg of Acetaminophen, which is about six times the maximum recommended daily dose of acetaminophen (4,000 mg).
The full recall can be found at www.fda.gov/Safety/Recalls/ucm357909.htm?source=govdelivery.