Skip to content
Recall Observatory FDA recall evidence

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

February 15, 2013

Class II

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

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility