Recall: Enteric-Coated Aspirin Product Contains Acetaminophen

Advance Pharmaceuticals is conducting a voluntary recall of the over-the-counter drug, Rugby label Enteric-Coated Aspirin Tablets, 81mg, Lot 13A026 after receiving a complaint about a bottle labeled as Enteric Coated Aspirin Tablets, 81mg actually containing Acetaminophen 500mg tablets.

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). 

Such high acetaminophen doses can lead to severe liver damage especially in those already taking drugs containing acetaminophen, or in people who consume 3 or more alcoholic drinks every day, or those who have liver disease.

The affected lot of Enteric Coated Aspirin Tablets is Lot 13A026 with Expiration Date 01-2015. The lot was manufactured and packaged by Advance Pharmaceutical Inc. under the label of Rugby Laboratories.

For more information visit FDA.gov.