Drug product
GUAIFENESIN AND DEXTROMETHORPHAN 100 mg-10 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 0904-6844-70
D-1490-2022
Product summary
- Event
- Event 90398
- Status
- Terminated
- Classification
- Class II
- Quantity
- 280,500 cups
- Official record key
drug-enforcement:D-1490-2022
Official wording
Reason: CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Code information: Lot # 20091A, EXP Sep. 2022; 20104A, EXP Nov. 2022; 21013A, EXP Feb. 2023; 21041A, EXP Apr. 2023; 21102A, EXP Sep. 2023; 21121A, 21127A, EXP Nov. 2023; 22003A, 22007A, EXP Jan. 2024; 22016A, EXP Mar. 2024
Distribution pattern: Distributed Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations