Safety Alerts & Recalls
What does this mean?
Unknowingly taking acetaminophen, especially in large quantities, can be dangerous and this alert should be taken seriously. Please check your supply of aspirin and see if you have any of the recalled product: Rugby label Enteric Coated Aspirin Tablets, 81 mg from lot 13A026
The recalled product was packaged in bottles of 120 tablets with the following codes: NDC 0536-3086-41 and UPC 3 0536-3086-41 9. To view a photo of the product label, please visit: http://www.fda.gov/Safety/Recalls/ucm357917.htm
If you have the affected lot number, you should immediately stop using it and return it to the pharmacy or store where it was purchased. Please contact your doctor or healthcare provider if you have experienced any problems that may be related to taking or using this recalled product.
Healthcare providers and patients are encouraged to report side effects related to the use of medicines to the FDA's MedWatch Program by telephone at 1-800-332-1088, by fax at 1-800-332-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.
One Lot of Rugby Labeled Enteric Coated Aspirin 81 mg Tablets Recalled - May Contain Acetaminophen 500 mg Tablets
Advance Pharmaceutical Inc. is conducting a voluntary nationwide recall to the customer level of a single lot of the over-the-counter drug, Rugby label Enteric Coated Aspirin Tablets, 81 mg. Lot 13A026 is being recalled due to a complaint about a bottle labeled as Enteric Coated Aspirin Tablets, 81 mg, which actually contains Acetaminophen 500 mg Tablets. The recalled product is indicated for the temporary relief of minor aches and pains and is packaged in bottles of 120 tablets with the following codes: NDC 0536-3086-41 and UPC 3 0536-3086-41 9.
Consumers who take Rugby label Enteric Coated Aspirin Tablets, 81 mg from lot 13A026 may be unknowingly taking acetaminophen 500 mg instead of Enteric Coated Aspirin 81 mg. This may cause severe liver damage to people in any of the following categories: --- Those who take other drugs containing acetaminophen.
--- Those who drink 3 or more alcoholic drinks per day.
--- Those who have liver disease.
The labeled directions for this recalled product instructs patients to take 4-8 tablets every 4 hours, but not more than 48 tablets in 24 hours. Consumers who take 4-8 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).
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