Multi-event July 2014 FDA Recall Sodium Chloride by Baxter Healthcare Corp.
This Multi-event Class I drug recall was voluntarily initiated by Baxter Healthcare Corp. on July 11, 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.
Reported Recall Events
Recall Number: D-1591-2014
Presence of Particulate Matter: particulate matter identified as fibers and/or plastics.
07-11-2014
09-24-2014
a) 217,536 bags; b) 161,760 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, Puerto Rico, Singapore, and Hong Kong
09-21-2016
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
0.9% Sodium Chloride Injection USP, packaged in a) 50 mL VIAFLEX Container bags, NDC 0338-0049-41, Product Code 2B1306; and b) 100 mL VIAFLEX Container bags, NDC 0338-0049-18, Product Code 2B1302, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA.
Batch or Lot Expiration Information
Lot# : a) P309187, Exp 10/14; b) P298190, Exp 08/14
Affected Packages Involved in this Recall
Recall Number: D-1593-2014
Presence of Particulate Matter: particulate matter identified as fibers and/or plastics
07-11-2014
09-24-2014
171,672 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, Puerto Rico, Singapore, and Hong Kong
09-21-2016
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Potassium Chloride Injection, 20 mEq per 50 mL, 50 mL Sterile Single Dose Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 0338-0703-41, Product Code 2B0822.
Batch or Lot Expiration Information
Lot# : P309476, Exp 10/14
Affected Packages Involved in this Recall
Recall Number: D-1592-2014
Presence of Particulate Matter: particulate matter identified as fibers and/or plastics.
07-11-2014
09-24-2014
390,560 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, Puerto Rico, Singapore, and Hong Kong
09-21-2016
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
0.9% Sodium Chloride Injection USP MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-0553-18, Product Code 2B0043.
Batch or Lot Expiration Information
Lot# : P308650, Exp 10/14
