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Recall Observatory FDA recall evidence

Drug product

Fluconazole Injection, USP, 200 mg/100 mL (2mg/mL), 100 mL Single-Dose Intravia Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Product Code 2J1446, NDC 0338-6046-48.

D-0206-2017

December 06, 2016

Class II

Product summary

Firm
Baxter Healthcare Corporation
Event
Event 75831
Status
Terminated
Classification
Class II
Quantity
30,910 bags
Official record key
drug-enforcement:D-0206-2017

Official wording

Reason: Lack of Assurance of Sterility: confirmed customer complaints of leaking bags.

Code information: Lot #: P344028 on bags, P344028A on shipping container, Exp 12/31/2017

Distribution pattern: United States, United Arab Emirates, and Colombia

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility