One lot of Rugby Laboratories enteric coated aspirin tablets, 81 mg, has been recalled to the user level. The manufacturer, Advance Pharmaceutical Inc, initiated a voluntary recall of Lot 13A026 (expiration January 2015) due to a complaint that a bottle labeled as enteric coated aspirin tablets, 81 mg, actually contained acetaminophen 500 mg tablets. This over-the-counter product is packaged in bottles of 120 tablets with National Drug Code 0536-3086-41 and Universal Product Code 3 0536-3086-41 9. The affected lot was distributed nationwide to wholesalers and retailers. The manufacturer warns that consumers may be inadvertently taking acetaminophen, 500 mg, instead of enteric coated aspirin, 81 mg, and that if they follow the directions on the labeling, they would be in danger of an acetaminophen overdose and severe liver damage. The manufacturer indicates that the package directions instruct “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).”

Consumers who have bottles from the affected lot should stop using the product and return it to the pharmacy or store where it was purchased, indicates Advance Pharmaceutical Inc. Consumers should contact a health care provider if they are experiencing any problems that may be related to using the product. Any adverse reactions related to the use of the product should be reported to the Food and Drug Administration's MedWatch Program.