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Recall Observatory FDA recall evidence

Drug product

Milrinone Lactate in 5% Dextrose Injection, 20 mg/100 mL, 100 mL Single-Dose Intravia Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 0338-6010-48

D-0789-2017

May 15, 2017

Class II

Product summary

Firm
Baxter Healthcare Corporation
Event
Event 77247
Status
Terminated
Classification
Class II
Quantity
90,450 bags
Official record key
drug-enforcement:D-0789-2017

Official wording

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

Code information: Lot #: P342485, Exp 11/30/17; P344408, Exp 12/31/17

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