September 2015 FDA Recall Sodium Chloride by Baxter Healthcare Corporation
D-1816-2015 - Lack of Assurance of Sterility
This Class II drug recall was voluntarily initiated by Baxter Healthcare Corporation on September 2, 2015 for the product Sodium Chloride. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1816-2015
Lack of Assurance of Sterility: Recalling firm reported a complaint for mold on the interior surface of the overpouch.
09-02-2015
09-30-2015
139,104 Bags
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Baxter Healthcare Corporation
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and Puerto Rico
09-15-2016
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# : P329821, Exp 08/31/2016
