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
Product summary
- 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
Lack of Assurance of Sterility