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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-0788-2017

May 15, 2017

Class II

Product summary

Firm
Baxter Healthcare Corporation
Event
Event 77247
Status
Terminated
Classification
Class II
Quantity
113,590 bags
Official record key
drug-enforcement:D-0788-2017

Official wording

Reason: Lack of assurance of sterility: customer complaints received for the presence of leaks.

Code information: Lot #: P344028/P344028A, Exp 12/31/17; P352377, Exp 8/31/18; P348136, Exp 4/30/18

Distribution pattern: US and foreign countries: United Arab Emirates, Colombia, and Canada

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of assurance of sterility