Drug product
Acetaminophen Oral Solution, USP 650mg/ 20.3 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Distributed by Major Pharmaceuticals, Livonia, MI 48152, NDC: 0904-6820-76.
D-0869-2022
Product summary
- Event
- Event 89879
- Status
- Completed
- Classification
- Class II
- Quantity
- 121,800 Unit Dose cups
- Official record key
drug-enforcement:D-0869-2022
Official wording
Reason: CGMP Deviations: Failure to properly investigate failed microbial testing.
Code information: Lot: 20040A, EXP May 2022
Distribution pattern: Distributed in Indiana for further distribution in the USA.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations