BETHESDA, MD 20 June 2013—Advance Pharmaceutical Inc. of Holtsville, New York, has recalled a single lot of 81-mg enteric-coated aspirin tablets that may instead contain acetaminophen.
A copy of the company's press release, dated June 19, states that the company received a complaint that one bottle of lot 13A206 contained 500-mg acetaminophen tablets, not aspirin.
The recalled lot is sold under the Rugby Laboratories label in bottles containing 120 tablets each, with an expiration date of 01-2015, according to the company. The product was distributed nationwide to wholesalers and retail stores.
The label for the aspirin product states that the maximum recommended dosage of the drug is 48 tablets per day. A patient who inadvertently takes 48 500-mg acetaminophen tablets would ingest 24,000 mg of that drug, or six times the recommended maximum daily amount.
Images of the Rugby labels are available at FDA's Dailymed product information website.
The recall notice instructs consumers who purchased the recalled lot to stop using it immediately and return it to the place of purchase. Consumers should speak with their health care provider about any medical problems that may be related to ingesting the drug.
Consumers with questions about the recall may contact the company by calling 631-981-4600, Monday through Friday, 9:00 a.m.–5:00 p.m., and selecting "0" to speak with the operator.