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Medication Safety Alerts

Acetaminophen 500 mg Tablets Voluntary Recall

10/15/2015

On October 15, 2015, the United States Food and Drug Administration (FDA) issued a notice about a voluntary recall of acetaminophen 500 mg tablets manufactured by Medline Industries, Inc. This recall was issued because it was labeled with the wrong strength. The acetaminophen 500 mg tablets were labeled incorrectly as acetaminophen 325 mg tablets. This could cause members to take a higher dose of acetaminophen than intended which could cause liver problems.

This may represent a potential health hazard or safety risk to plan members who may be using product affected by this recall.

This recall affects lot number 45810 exp. 05/2018. To see if you have affected product, please check the lot number. The lot number is located on the bottom of the manufacturer’s bottle below the barcode. If your product is not from lot number 45810, it is not affected by this recall. If your product is from lot number 45810, please return it to the pharmacy that filled your prescription.

Please call your doctor right away for advice if you may be using affected product or if you do not know if you used affected product or not. Your doctor is familiar with your medical history and can suggest the best treatment option for you. If you need a prescription for a different medicine, please contact your doctor.

CVS/caremark Response: This product is not carried by the CVS/caremark Mail Service Pharmacies.

If you are currently taking acetaminophen 500 mg tablets and have questions regarding this recall, please call your doctor or call Medline Industries, Inc. toll-free at 1‑866‑359‑1704.You may also call the FDA consumer inquiry line toll-free at 1‑888‑INFO‑FDA (1‑888‑463‑6332) or visit their Web site at https://www.fda.gov/Safety.

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