Drug Safety Alerts

Acetaminophen 325 mg Tablets Class I Recall

2/26/2016

On February 26, 2016 the United States Food and Drug Administration (FDA) issued notice regarding a Class I recall of acetaminophen 325 mg tablets NDC # 53329-0642-30 manufactured by Medline Industries, Inc. This recall was issued because the acetaminophen 500 mg tablets 100 count bottle (OTC20101) has been found to be mislabeled displaying “Acetaminophen 325 mg” (OTC10101) instead of “Acetaminophen 500 mg”. The acetaminophen 500 mg is incorrectly labeled as 325 mg tablets.

This recall affects lot number 45810 exp. 05/18.

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.

CVS/caremark Response:

Please note: This product is not carried by the CVS/caremark Mail Service Pharmacies.

For more information about this recall, health care providers may contact Medline Industries, Inc. at 1‑866-359-1704 Monday through Friday, 8:00 am and 5:00 pm (CST). You may also contact the FDA consumer inquiry at 1‑888‑INFO-FDA (1‑888-463-6332) or visit their Web site accessdata.fda.gov/scripts/.