December 2014 FDA Recall Sodium Chloride by Baxter Healthcare Corp
D-481-2015 - Presence of Particulate Matter
This Class I drug recall was voluntarily initiated by Baxter Healthcare Corp on December 4, 2014 for the product Sodium Chloride. The FDA reported the reason for recall as presence of particulate matter. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-481-2015
Presence of Particulate Matter: Confirmed customer complaints received for the presence of blue plastic, identified as fragments of the frangible from the vial adapter.
12-04-2014
04-15-2015
542,080 container bags
Recall Profile & Regulatory Data
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
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.
Nationwide and Puerto Rico.
04-14-2017
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 Plus Container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, Product Code 2B0043, NDC 0338-0553-18.
Batch or Lot Expiration Information
Lot# : P317891, P317842, Exp 05/15
