Drug product
METRONIDazole Injection, USP 500 mg (5 mg/mL) in 100 mL Single Dose Flexible Container, Rx only, For IV Use, Hospira Inc., Lake Forest, IL --- NDC 0409-7811-24
D-0480-2017
Product summary
- Event
- Event 76460
- Status
- Terminated
- Classification
- Class II
- Quantity
- 578,784 bags
- Official record key
drug-enforcement:D-0480-2017
Official wording
Reason: Lack of Sterility Assurance: customer report of leaking bag
Code information: Lot: 54-054-JT, 6/1/2017
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Sterility assurance
Lack of Sterility