Pain Reliever Recalled

Plastikon Healthcare is recalling numerous lots of acetaminophen oral solution labeled by Major Pharmaceuticals. According to the September 14, 2022, US Food and Drug Administration (FDA) Enforcement Report, the medication was manufactured under conditions that reflect inadequately controlled manufacturing processes.

The recall affects the following products, which were distributed throughout the United States:

• acetaminophen oral solution 160 mg/5 mL, 5-mL cups, packaged 10 cups per tray, 10 trays per carton (NDC 0904-6738-70), for institutional use only, Major Pharmaceuticals, from lots 20078A and 20083A (Exp. 8/22), 20092A (Exp. 9/22), 21058A and 21048C (Exp. 5/23), 21063C (Exp. 6/23), 21093B (Exp. 9/23), 22001C (Exp. 1/24), and 22017A (Exp. 3/24);
• acetaminophen oral solution, 325 mg/10.15 mL, 10.15-mL cups, packaged 10 cups per tray, 10 trays per carton (NDC 0904-6739-71), for institutional use only, Major Pharmaceuticals, from lots 20062A and 20067A (Exp. 6/22), 20092A and 20093A (Exp. 9/22), 20101A and 21110A (Exp. 10/22), 20108A (Exp. 11/22), 21012A (Exp. 1/23), 21044A and 21048B (Exp. 4/23), 21053A (Exp. 5/23), 21063B and 21068B (Exp. 6/23), 21084B (Exp. 7/23), 21090A (Exp. 8/23), 21119A (Exp. 11/23), 21122B (Exp. 12/23), 22001B and 22006A (Exp. 1/24), and 22017B (Exp. 3/24); and
• acetaminophen oral solution, 650 mg/20.3 mL, 20.3-mL cups, packaged 10 cups per tray, 10 trays per carton (NDC 0904-6820-76), for institutional use only, Major Pharmaceuticals, from lots 20064A and 20066A (Exp. 6/22), 20069A and 20073A (Exp. 7/22), 20094A, 20094B, 20095A, and 20095B (Exp. 9/22), 20103A (Exp. 10/22), 20105A (Exp. 11/22), 20111A and 20111B (Exp. 12/22), 21005A and 21005B (Exp. 1/23), 21019A and 21019B (Exp. 2/23), 21035A, 21035B, and 21038A (Exp. 3/23), 21048A and 21048D (Exp. 4/23), 21058B (Exp.  5/23), 21063A and 21068A (Exp. 6/23), 21084A (Exp. 7/23), 21090B (Exp. 8/23), 21093A (Exp. 9/23), 21124A and 21126A (Exp. 11/23), 21136A, 20112A, 21122A, 21122C, and 20112B (Exp.  12/23), 22001A, 22001D, 22006B, and 22006C (Exp. 1/24), 22010A, 22011A, and 22011B (Exp. 2/24), and 22014A, 22015A, and 22021A (Exp. 3/24).

Plastikon Healthcare voluntarily initiated the recall June 7, 2022. On September 6, 2022, the FDA designated the recall Class II. Medications 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 is used to treat mild to moderate pain and to reduce fever.