FDA-Drug2015-09-30Class II

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

Baxter Healthcare Corporation
Hazard

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

Sold states
Nationwide and Puerto Rico
Affected count
139,104 Bags
Manufactured in
Road #144, #250, N/A, Jayuya, PR, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1816-2015

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