Drug product
Magnesium Hydroxide 2400 mg, Aluminum Hydroxide 2400 mg, Simethicone 240 mg MAX, per 30 mL Oral Suspension, 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 0904-6839-73
D-1483-2022
Product summary
- Event
- Event 90398
- Status
- Terminated
- Classification
- Class II
- Quantity
- 88,500 cups
- Official record key
drug-enforcement:D-1483-2022
Official wording
Reason: CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Code information: Lot # 20084A, 20086A, EXP Aug. 2022; 21074A, 21077A, EXP Jul. 2023
Distribution pattern: Distributed Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations