Drug product
GUAIFENESIN AND DEXTROMETHORPHAN 200-20 mg/10 mL, 10 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 0904-6980-72
D-1491-2022
Product summary
- Event
- Event 90398
- Status
- Terminated
- Classification
- Class II
- Quantity
- 246,200 cups
- Official record key
drug-enforcement:D-1491-2022
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; 21017A, EXP Feb. 2023; 21034A, 21036A EXP Mar. 2023; 21092A, EXP Aug. 2023; 21105A, 21106A, EXP Oct. 2023; 21134A, EXP Dec. 2023; 22007B, EXP Jan. 2024; 22012A, EXP Feb. 2024; 22016B, EXP Mar. 2024
Distribution pattern: Distributed Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations