FDA recall D-1816-2015

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

Reason for recall

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

Distribution

Nationwide and Puerto Rico

Key facts

Status

Terminated

Initiation date

2015-09-02

Report date

2015-09-30

Termination date

2016-09-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Jayuya, PR, United States

Primary source

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