Pain Reliever in Kits Distributed by Humana Involved in Class I Recall

A-S Medication Solutions is recalling extra-strength acetaminophen included in Health Essentials Kits that Humana distributed to members, according to the May 12, 2021, US Food and Drug Administration (FDA) Enforcement Report. 

An April 2, 2021, company announcement explained the extra-strength acetaminophen being recalled contained an incomplete prescription drug label rather than the required OTC Drug Facts label. On April 30, 2021, the FDA designated the recalls Class I, suggesting use of the affected product could cause serious adverse health consequences or death. 

The recall affects 198,350 bottles of acetaminophen extra strength, 500-mg tablets in 100-count bottles (NDC 50090-5350-0). The tablets are packaged in white plastic bottles included in a clear plastic bag with other seasonal products, such as hand sanitizer, a reusable face mask, a bag of cough drops, a digital thermometer, and disposable gloves. 

The extra-strength acetaminophen bottles that should be returned are from lots 323206, 323207, 323208, 335353, 335354, 335355, 335356, 335358, 335359,335360, 335361, 335362, 335395, and 352116 (Exp. 7/31/22); and 323209, 323210, 323211, 323212, 323213, 323214, 323215, 323216, 323218, 323219, 323220, 323222, 323223, 323224, 323238, 335363, 335364, 335365, 335366, 335367, 335368, 335369, 335370, 335371, 335372, 335373, 335374, 335375, 335376, and 335377 (Exp. 8/31/22). 

The product was manufactured by Major Pharmaceuticals, Livonia, MI, and packaged by A-S Medication Solutions, Libertyville, IL. The kits were distributed by Humana throughout the United States between January 14, 2021, and March 15, 2021.  

A-S Medication Solutions voluntarily initiated the recall March 2, 2021.

Extra-strength acetaminophen is an over-the-counter pain reliever and fever reducer.

—Jolynn Tumolo