Drug product
Diphenhydramine HCl Oral Solution 12.5 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 0904-6740-70
D-1488-2022
Product summary
- Event
- Event 90398
- Status
- Terminated
- Classification
- Class II
- Quantity
- 217,700 cups
- Official record key
drug-enforcement:D-1488-2022
Official wording
Reason: CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Code information: Lot # 20063A, EXP Jun. 2022; 20098A, EXP Oct. 2022; 21055B, EXP May. 2023; 21066A, EXP Jun. 2023; 21083B, EXP Jul. 2023; 21112B, EXP Oct. 2023; 22009A, EXP Feb. 2024.
Distribution pattern: Distributed Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations