Libertyville, IL, A-S Medication Solutions, LLM (ASM) is voluntarily recalling 198,350 bottles of Acetaminophen Extra Strength 500 mg Tablets, 100 ct. bottles (NDC# 50090-5350-0) contained in Health Essentials Kits distributed by Humana to its members.This recall is being conducted to the consumer level. These over-the-counter (OTC) analgesic products contain an incomplete prescription drug label rather than the required OTC Drug Facts label.
Risk Statement: Use of acetaminophen could be potentially harmful if safety warnings contained on the OTC label are not observed including: liver damage if consumers exceed the recommended dose, combine use with excessive consumption of alcohol, or are allergic to the active ingredient. To date, the Company has not received any reports of adverse events related to this recall.
The product is used as a pain and fever reliever. The 100-count bottles labeled with NDC 50090-5350-0 are packaged in white plastic bottles contained in a clear plastic bag with other seasonal products labeled as a Health Essentials Kit. Distribution likely occurred between 1/14/21 and 3/15/21 nationwide in the USA. Expiration dates are either 7/31/22 or 8/31/22. The affected bottles that should be returned contain a short Rx drug label that lacks the full OTC Drug Facts chart.
ASM is also notifying its distributors and customers by mail and is arranging for return of all recalled products. Consumers and distributors that have this product which is being recalled should stop using it and return it in preaddressed return mailers that will be provided by ASM or the distributors.
NDC # 50090-5350-0
Lot #s 323206, 323207, 323208, 323209, 323210, 323211, 323212, 323213, 323214, 323215, 323216, 323218, 323219, 323220, 323222, 323223, 323224, 323238, 335353, 335354, 335355, 335356, 335358, 335359, 335360, 335361, 335362, 335363, 335364, 335365, 335366, 33536, 335368, 335369, 335370, 335371, 335372, 335373, 335374, 335375, 335376, 335377, 335395, and 352116.
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