Acetaminophen Oral Solution, USP 650mg/ 20.3 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Distributed by Major Pharmaceuticals, Livonia, MI 48152, NDC: 0904-6820-76.

Recall Number: D-0869-2022

Firm: Plastikon Healthcare LLC

Classification: Class II

Status: Completed

Report Date: 20220525

Initiation Date: 20220324

Termination Date:

CGMP Deviations: Failure to properly investigate failed microbial testing.

Acetaminophen Oral Solution, USP 650mg/ 20.3 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Distributed by Major Pharmaceuticals, Livonia, MI 48152, NDC: 0904-6820-76.