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Recall Observatory FDA recall evidence

Drug product

Metronidazole Injection USP, RTU, 500 mg/100mL in Viaflex Plus Container, Baxter, Deerfield, IL 60015, NDC 0338-1055-48

D-629-2013

May 21, 2013

Class II

Product summary

Firm
Baxter Healthcare Corp.
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

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility