- Company Announcement Date:
- April 02, 2021
- FDA Publish Date:
- April 02, 2021
- Product Type:
- Reason for Announcement:
Products contain an incomplete prescription drug label
- Company Name:
- A-S Medication Solutions, LLM
- Brand Name:
A-S Medication Solutions, LLM
- Product Description:
Acetaminophen Extra Strength 500 mg Tablets, 100 ct. bottles contained in Health Essentials Kits distributed by Humana
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. See the photo below. 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.
Consumers with questions regarding this recall can contact ASM by telephone at 847.680.3515 x 236, from 9-5 p.m. CST, or e-mail at [email protected]. Consumers should contact their physician or healthcare provider if they experience any problems that may be related to taking or using this or any drug product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online
- Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.