Drug product
Amino Acid Injection 50 g/1000 mL (50 mg/mL) bags, Rx Only, Nephron 503B outsourcing facility, 4500 12th Extension, West Columbia, SC 29172, NDC: 69374-988-10
D-1245-2022
Product summary
- Event
- Event 90512
- Status
- Terminated
- Classification
- Class II
- Quantity
- 163 bags
- Official record key
drug-enforcement:D-1245-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lots: AA2012A, Exp. 07/04/2022
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility