Drug product
Metronidazole Injection USP, RTU, 500 mg/100mL in Viaflex Plus Container, Baxter, Deerfield, IL 60015, NDC 0338-1055-48
D-629-2013
Product summary
- Event
- Event 65288
- Status
- Terminated
- Classification
- Class II
- Quantity
- 172,296 units
- Official record key
drug-enforcement:D-629-2013
Official wording
Reason: Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port.
Code information: Lot #: P280123, P280123A, Exp 2/14
Distribution pattern: Nationwide & Puerto Rico
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility