Drug product
CALCIUM CARBONATE ORAL SUSPENSION, 1250 mg/5 mL, 5 mL cup, packaged in 10 cups per tray, 4 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr. Suite 233, Livonia, MI 48152, NDC 0904-7098-94
D-1487-2022
Product summary
- Event
- Event 90398
- Status
- Terminated
- Classification
- Class II
- Quantity
- 49,280 cups
- Official record key
drug-enforcement:D-1487-2022
Official wording
Reason: CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Code information: Lot # 21021A, 21023A, 21024A, EXP Feb. 2023; 21064A, EXP Jun. 2023; 21073A, 21075A, EXP Jul. 2023; 21100A, EXP Sep. 2023; 21118A, 21120A, EXP Nov. 2023; 21128A, 21129A, 21131A, 21135A, EXP Dec. 2023; 22019A, EXP Mar. 2024.
Distribution pattern: Distributed Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations