Medline brand acetaminophen tablets (500 mg tabs mislabeled as 325 mg)

0101ABA

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Medline Industries, Inc. announced that it will initiate a voluntary nationwide recall of lot # 45810 of Acetaminophen tablets, 500mg, uncoated compressed tablets to the consumer level. The Acetaminophen 500mg, Tab 100/BT (OTC20101) has been found to be mislabeled displaying “Acetaminophen 325mg” (OTC10101) instead of “Acetaminophen 500mg”. The Acetaminophen tablets, 500mg is incorrectly labeled as 325 mg tablets.

This error is not easily identifiable by the user or prescriber. If the product is taken at the maximum labeled dose, every four hours, five doses a day, or with other medications containing acetaminophen, it may lead to liver toxicity or liver failure.
(...)
This item is packaged as 100 tablets per bottle, Medline Item Number: OTC20101, NDC#: 53329-641-30. The recalled Acetaminophen 500mg, Tab 100/BT (OTC20101) includes lot # 45810 with expiration date May 2018.

This lot was distributed nationwide from June 12, 2015 through September 18, 2015. (...) Consumers, distributors, and/or retailers that have product which is being recalled should stop using and return to Medline Industries, Inc.

http://www.fda.gov/Safety/Recalls/ucm467049.htm
 

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