Drug product
Acetaminophen Oral Solution 160 mg / 5 mL, 5 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 0904-6738-70
D-1484-2022
Product summary
- Event
- Event 90398
- Status
- Terminated
- Classification
- Class II
- Quantity
- 290,270 cups
- Official record key
drug-enforcement:D-1484-2022
Official wording
Reason: CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Code information: Lot# 20078A, 20083A EXP Aug. 2022; 20092A, EXP Sep. 2022; 21058A, 21048C, EXP May. 2023; 21063C, EXP Jun. 2023; 21093B, EXP Sep. 2023; 22001C, EXP Jan. 2024; 22017A, EXP Mar. 2024.
Distribution pattern: Distributed Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations