Drug product
METRONIDazole Injection, USP 500 mg (5 mg/mL), 100 mL Bag, Rx only, Hospira, Inc. Lake Forest, IL 60045 (NDC 0409-7811-24)
D-206-2013
Product summary
- Firm
- Hospira Inc.
- Event
- Event 64482
- Status
- Terminated
- Classification
- Class II
- Quantity
- 567,624 bags
- Official record key
drug-enforcement:D-206-2013
Official wording
Reason: Lack of Assurance of Sterility: There is the potential for the solution to leak from the administrative port to the fill tube seal.
Code information: Lot code 12-074-JT Exp 12/13
Distribution pattern: Nationwide.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility