Product name: “Rugby” Enteric Coated Aspirin Tablets, 81 mg.
Manufacturer: Advance Pharmaceutical Inc.
Reason for recall: Consumers may be inadvertently taking 500 milligrams of acetaminophen instead of 81 milligrams of enteric coated aspirin, which may cause severe liver damage to those who take other drugs containing acetaminophen, those who drink three or more alcoholic drinks every day, or who have liver disease.
The labeled directions instructs patients to take four to eight tablets every four 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 milligrams of acetaminophen, about six times the maximum recommended daily dose.
Affected lots: 120-count bottles, Lot 13A026 with expiration date of 01-2015.
Illnesses, injuries or deaths related to problem: None noted in U.S. Drug and Food Administration press release.
What to do with the product: Discontinue use and return to place of purchase. For more information call 631-981-4600.