July 2015 FDA Recall Sodium Chloride by Baxter Healthcare Corp.
D-1326-2015 - Presence of Particulate Matter and Lack of Assurance of Sterility
This Class II drug recall was voluntarily initiated by Baxter Healthcare Corp. on July 2, 2015 for the product Sodium Chloride. The FDA reported the reason for recall as presence of particulate matter and lack of assurance of sterility. The product was distributed in TX and TN and the recall is currently terminated.
Recall Number: D-1326-2015
Presence of Particulate Matter and Lack of Assurance of Sterility: The firm received a complaint for customer of presence of particulate matter, leaky containers, and missing port protectors.
07-02-2015
08-19-2015
189,912 containers
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 Corp.
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.
TX and TN
05-26-2016
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
0.9% Sodium Chloride Injection USP, 500 mL in VIAFLEX Plastic Container, Baxter Healthcare Corporation Deerfield, IL 60015, NDC 0338-0049-03.
Batch or Lot Expiration Information
Lot# : C964601, Exp 4/30/2016
