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Recall Observatory FDA recall evidence

Drug product

0.9% Sodium Chloride Injection, USP, 100 mL MINI-BAG VIAFLEX Container, Single Dose Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-0049-38

D-1816-2015

September 02, 2015

Class II

Product summary

Firm
Baxter Healthcare Corporation
Event
Event 72060
Status
Terminated
Classification
Class II
Quantity
139,104 Bags
Official record key
drug-enforcement:D-1816-2015

Official wording

Reason: Lack of Assurance of Sterility: Recalling firm reported a complaint for mold on the interior surface of the overpouch.

Code information: Lot #: P329821, Exp 08/31/2016

Distribution pattern: Nationwide and Puerto Rico

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility