Drug product

Acetaminophen Oral Solution, 325 mg / 10.15 mL, 10.15 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr. Suite 233, Livonia, MI 48152, NDC 0904-6739-71

D-1485-2022

June 07, 2022

Class II

Product summary

Firm: Plastikon Healthcare LLC
Event: Event 90398
Status: Terminated
Classification: Class II
Quantity: 848,500 cups
Official record key: drug-enforcement:D-1485-2022

Official wording

Reason: CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.

Code information: Lot # 20062A, 20067A, EXP Jun. 2022; 20092A, 20093A, EXP Sep. 2022; 20101A, 21110A, EXP Oct. 2022; 20108A, EXP Nov. 2022; 21012A, EXP Jan. 2023; 21044A, 21048B, EXP Apr. 2023; 21053A, EXP May. 2023; 21063B, 21068B, EXP Jun. 2023; 21084B, EXP Jul. 2023; 21090A, EXP Aug. 2023; 21119A, EXP Nov. 2023; 21122B, EXP Dec. 2023; 22001B, 22006A, EXP Jan. 2024; 22017B, EXP Mar. 2024

Distribution pattern: Distributed Nationwide in the USA

Derived failure modes

Manufacturing or process control
reason.manufacturing_process_control · v1.0.0

CGMP Deviations