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-1479-2022
Product summary
- Event
- Event 90398
- Status
- Terminated
- Classification
- Class I
- Quantity
- 43,200 cups
- Official record key
drug-enforcement:D-1479-2022
Official wording
Reason: Microbial Contamination of Non-Sterile Products.
Code information: Lot #: 20051A, EXP Aug. 2022; 20088A, EXP Sep. 2022.
Distribution pattern: Distributed Nationwide in the USA
Derived failure modes
-
Microbial contamination
Microbial Contamination