Multi-event March 2015 FDA Recall Sodium Chloride by Baxter Healthcare Corp
This Multi-event Class II drug recall was voluntarily initiated by Baxter Healthcare Corp on March 23, 2015 for the product Sodium Chloride. The FDA reported the reason for recall as lack of assurance of sterility; increased complaints received for leaks. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
Recall Number: D-0428-2015
Lack of Assurance of Sterility; increased complaints received for leaks
03-23-2015
04-08-2015
7444 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.
Nationwide and Singapore
10-20-2016
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Clinimix E 5/20 sulfite-free (5% amino-acid with electrolytes in 20% dextrose with calcium) Injection, 2000 mL in Dual Chamber Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL --- Product code 2B7722, NDC 0338-1125-04
Batch or Lot Expiration Information
Lot# Product code: 2B7722
Lot# : P306365, exp date: 8/31/2015
Affected Packages Involved in this Recall
Recall Number: D-0429-2015
Lack of Assurance of Sterility; increased complaints received for leaks
03-23-2015
04-08-2015
196,128 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.
Nationwide and Singapore
10-20-2016
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
0.9% Sodium Chloride Injection, USP, 50 mL, VIAFLEX Plastic Container Multi Pack, Rx Only, Baxter Healthcare Corporation, Deerfield, IL , Product code 2B1308, NDC 0338-0049-31
Batch or Lot Expiration Information
Lot# Product code: 2B1308
Lot# : P316497, exp date: 10/2015
