Acetaminophen in Health Essentials Kits Recalled Due to Mislabeling

April 2, 2021 – A-S Medication Solutions (ASM) has voluntarily recalled 198,350 bottles of Acetaminophen Extra Strength 500mg Tablets, 100-count bottles (NDC# 50090-5350-0) contained in Health Essentials Kits. The kits were distributed by Humana to its members. The recalled acetaminophen is an over-the-counter (OTC) product that was mislabeled with an incomplete prescription drug label rather than the required OTC Drug Facts label.

While generally safe for OTC use, acetaminophen (the generic version of Tylenol®) can pose a danger if safety warnings on the OTC label are not observed. These warnings include potential for liver damage if the recommended dose is exceeded or the drug is used concurrently with excessive consumption of alcohol. As of the date of the recall, ASM had not received any reports of adverse events related to the affected product.

The Healthcare Essentials Kits consist of a labeled, clear plastic bag filled with several health products including a white plastic bottle containing the mislabeled acetaminophen. Affected bottles have a short prescription drug label that lacks the full OTC Drug Facts chart and were packaged in kits that were likely distributed between January 14, 2021, and March 15, 2021.

ASM is making arrangements for the return of the recalled acetaminophen and notifying distributors and customers by mail. The company advises individuals in possession of the product to stop using it and return it in preaddressed return mailers that will be provided by ASM or its distributors. Consumer questions should be directed to ASM at 1-847-680-3515 x236 or anel.figueroa@a-smeds.com. Individuals who have experienced any problems that may be related to using the recalled drug should contact their healthcare provider. Adverse events can also be reported to the U.S. FDA’s MedWatch program.

A full copy of the recall notice is available on the FDA’s website.

There is no member impact through Benecard Central Fill.