Multi-event November 2013 FDA Recall Dextrose by Baxter Healthcare Corp.
This Multi-event Class I drug recall was voluntarily initiated by Baxter Healthcare Corp. on November 21, 2013 for the product Dextrose. The FDA reported the reason for recall as presence of paticulate matter; baxter is issuing a voluntary recall for these iv solutions due to particulate matter found in the solution identified as polyester and cotton fibers, adhesive-like mixture, polyacetal particles, thermally degraded pvc, black polypropylene and human hair embedded in the plastic bag. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
Recall Number: D-1162-2014
Presence of Paticulate Matter; Baxter is issuing a voluntary recall for these IV solutions due to particulate matter found in the solution identified as polyester and cotton fibers, adhesive-like mixture, polyacetal particles, thermally degraded PVC, black polypropylene and human hair embedded in the plastic bag
11-21-2013
03-26-2014
105,216 containers
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, Saudi Arabia and United Arab Emirates.
09-21-2016
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
5% Dextrose Injection, USP, 100 mL Single dose VIAFLEX plastic containers, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Product code 2B0089, NDC 0338-0017-38.
Batch or Lot Expiration Information
Lot# : P285288, Exp 11/13
Affected Packages Involved in this Recall
Recall Number: D-1163-2014
Presence of Particulate Matter: Baxter is issuing a voluntary recall for these IV solutions due to particulate matter found in the solution identified as polyester and cotton fibers, adhesive-like mixture, polyacetal particles, thermally degraded PVC, black polypropylene and human hair embedded in the plastic bag
11-21-2013
03-26-2014
716,544 containers
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, Saudi Arabia and United Arab Emirates.
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 Single dose VIAFLEX plastic containers (Product code 2B1308, NDC 0338-0049-31) and b) 100 mL Single dose VIAFLEX plastic containers (Product code 2B1302, NDC 0338-0049-18) and (Product code 2B1309, NDC 0338-0049-38), Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA.
Batch or Lot Expiration Information
Lot# : a) P297283, Exp 08/14; b) P292326, Exp 04/14; P293993, Exp 05/14; and P293514, Exp 04/14
