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Recall Observatory FDA recall evidence

Drug product

DOPamine Hydrochloride and 5% Dextrose INJ, USP, 200 mg per 250 mL, Rx Only, Baxter USA, NDC 0338-1005-02.

D-0004-2015

September 29, 2014

Class II

Product summary

Firm
Baxter Healthcare Corp.
Event
Event 69303
Status
Terminated
Classification
Class II
Quantity
11,808 bags
Official record key
drug-enforcement:D-0004-2015

Official wording

Reason: Lack of Assurance of Sterility: A small cut in the solution bag may have been introduced during the manufacturing process, resulting in a leak of the bag into the overpouch.

Code information: Lot# P303172; Exp. 12/14

Distribution pattern: Nationwide and Canada

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility