Drug product
Magnesium Hydroxide 1200 mg, Aluminum Hydroxide 1200 mg, Simethicone 120 mg per 30 mL, 30 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 0904-6838-73
D-1482-2022
Product summary
- Event
- Event 90398
- Status
- Terminated
- Classification
- Class II
- Quantity
- 521,700 cups
- Official record key
drug-enforcement:D-1482-2022
Official wording
Reason: CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Code information: Lot # 20077A, 20080A, 20082A, EXP Aug. 2022; 21016A, EXP Feb. 2023; 21026A, EXP Mar. 2023; 21042A, 21047A, 21050A, EXP Apr. 2023; 21057A, 21059A, 21060A,EXP May. 2023; 21061A, 21067A, 21070A, 21072A, EXP Jun. 2023; 21095A, 21097A, 21099A, EXP Sep. 2023; 21107A, 21109A, 21111A, 21113A, EXP Oct. 2023; 21138A, EXP Dec. 2023; 22002A, 22004A, 22005A, EXP Jan. 2024
Distribution pattern: Distributed Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations