February 12, 2021
Discoloration and failure of the product to meet pH specifications has prompted AuroMedics Pharma to recall acetaminophen injections from multiple lots, according to the February 10, 2021, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects acetaminophen injection, 1000 mg per 100 mL (10 mg/mL), 100-mL single-dose vials for intravenous use only (NDC 55150-307-01), from lots CAT200002 (Exp. 9/22), CAT200004 (Exp. 9/22), CAT200005 (Exp 9/22), CAT200008 (Exp. 9/22), CAT200009 (Exp. 9/22), CAT200013 (Exp. 10/22), CAT200014 (Exp. 10/22), CAT200015 (Exp. 10/22), CAT200016 (Exp. 10/22), CAT200017 (Exp. 10/22), and CAT200018 (Exp. 10/22). The vials were distributed throughout the United States.
AuroMedics Pharma voluntarily initiated the recall December 30, 2020. The FDA designated the recall Class II on February 4, 2021, signaling use of the product could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.
Acetaminophen injections are a prescription treatment for mild to moderate pain and fever.