Some of the products were mislabeled with the incorrect dosage
October 16, 2015Image may be NSFW.
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Medline Industries, Inc. is recalling lot #45810 of its 500mg Acetaminophen tablets due to a labeling error. The company has found that many of its 500 mg Acetaminophen tablets have been mislabeled as 325 mg Acetaminophen tablets.
Because of the discrepancy, a consumer who takes the maximum labeled dose may inadvertently overdose on the product, which could lead to liver toxicity or liver failure. There have been no reported cases or adverse events associated with the product to date.
Acetaminophen is an over-the-counter (OTC) medication that can provide temporary relief for a wide variety of aches and pains. It is also known to reduce fever and stifle cold symptoms. The recalled product can be identified by the lot number denoted above, the medicine item number (OTC20101, NDC#: 53329-641-30), and the expiration date (May, 2018).
The product was distributed nationwide between June 12, 2015 and September 18, 2015. Distributors, retailers, and consumers who have the product should cease selling or using it immediately and return it to Medline Industries, Inc.
You can contact Medline Industries, Inc. with any questions or concerns, Monday through Friday, at 866-359-1704 between 8:00 a.m. and 5:00 p.m. CST. You can also contact the company via its online site here.
Additionally, any consumer that has experienced medical problems as a result of this product should contact their physician or healthcare provider. You can report any of these problems to the FDA’s MedWatch Adverse Event Reporting program, either online, by regular mail, or by fax.
You can submit this report at the web address here, download the form here, or call 1-800-332-1088 to request a reporting form. All forms should be returned to the address shown on pre-addressed form. Lastly, you can submit the form via fax at 1-800-FDA-0178.
