Analgesic Injection Solution Recalled

Baxter Healthcare Corporation is recalling 85,680 bags of acetaminophen injection. According to the August 24, 2022, US Food and Drug Administration (FDA) Enforcement Report, the bags were transported in refrigerated trucks with pallet labels that stated the product should be refrigerated upon arrival. However, the medication is labeled for storage in a controlled room-temperature environment.

The recall affects acetaminophen injection, 10 mg/mL, 1000 mg/100 mL, 100-mL bags (NDC 36000-306-60), from lots 20K19G64T1 (Exp. 10/31/22); 21K23G65, 21K25G65, 21K26G65, and 21K29G67 (Exp. 10/31/23); and 21L10G65, 21L13G66, 21L14G66, and 21L15G65 (Exp. 11/30/23). The product was distributed throughout the United States.

Baxter Healthcare Corporation voluntarily initiated the recall August 4, 2022. The FDA designated the recall Class II on August 16, 2022. Drugs affected by Class II recalls may cause temporary or medically reversible adverse health consequences if used. While remote, a possibility of serious harm also exists.

Acetaminophen injection solution is administered intravenously to treat mild to moderate pain and to reduce fever.