FDA MedWatch –  Acetaminophen Extra Strength Tablets Contained in Health Essentials Kits by A – S Medication Solutions :

TOPIC: Acetaminophen Extra Strength Tablets Contained in Health Essentials Kits by A-S Medication Solutions Due to Mislabeling

AUDIENCE: Consumer, Health Professional, Risk Manager, Pharmacy

ISSUE: A – S Medication Solution (ASM) is 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. These over-the-counter (OTC) analgesic products contain an incomplete prescription drug label rather than the required OTC Drug Facts label.

To date, A – S Medication Solution (ASM) has not received any reports of adverse events related to this recall.

For more information about this recall, click on the red button “Read Recall” below.

BACKGROUND: Acetaminophen is used as a pain and fever reliever. 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. 

RECOMMENDATION: 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 A – S Medication Solution (ASM) or the distributors.

Health professionals and consumers are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online.
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.