Multi-event March 2015 FDA Recall Dextrose by Baxter Healthcare Corp.
This Multi-event Class I drug recall was voluntarily initiated by Baxter Healthcare Corp. on March 24, 2015 for the product Dextrose. The FDA reported the reason for recall as presence of particulate matter. The product was distributed in US, Puerto Rico, and Bermuda and the recall is currently terminated.
Reported Recall Events
Recall Number: D-1210-2015
Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)
03-24-2015
07-15-2015
18,324 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.
US, Puerto Rico, and Bermuda
02-07-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
10% Dextrose Injection, USP, 250mL VIAFLEX Plastic bags, Manufactured by Baxter Healthcare Corporation 65 Pitts Station Road Marion, North Carolina 28752-7925 for Baxter Healthcare Corporation 1 Baxter Pkwy Deerfield, IL 60015-4625. NDC 0338-0023-02
Batch or Lot Expiration Information
Lot# : C965558 and C963520, Exp 7/31/2016
Affected Packages Involved in this Recall
Recall Number: D-1209-2015
Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)
03-24-2015
07-15-2015
402,284 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.
US, Puerto Rico, and Bermuda
02-07-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
5% Dextrose Injection, USP, 250mL VIAFLEX Plastic bags, Manufactured by Baxter Healthcare Corporation 65 Pitts Station Road Marion, North Carolina 28752-7925 for Baxter Healthcare Corporation 1 Baxter Pkwy Deerfield, IL 60015-4625. NDC 0338-0017-02
Batch or Lot Expiration Information
Lot# : C963413 and C963413A, Exp 7/31/2016
Affected Packages Involved in this Recall
Recall Number: D-1208-2015
Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)
03-24-2015
07-15-2015
202,824 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.
US, Puerto Rico, and Bermuda
02-07-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
0.9% Sodium Chloride Injection, USP, in 250mL VIAFLEX Plastic bags, Manufactured by Baxter Healthcare Corporation 65 Pitts Station Road Marion, North Carolina 28752-7925 for Baxter Healthcare Corporation 1 Baxter Pkwy Deerfield, IL 60015-4625. NDC 0338-0049-02
Batch or Lot Expiration Information
Lot# : C965038, C965293, C963785, C963884, C963660, C964320, C964486 and C964890, Exp 7/31/2016
Affected Packages Involved in this Recall
Recall Number: D-1211-2015
Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)
03-24-2015
07-15-2015
58,932 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.
US, Puerto Rico, and Bermuda
02-07-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Lactated Ringers Injection, USP, 250mL VIAFELX Plastic bags, Manufactured by Baxter Healthcare Corporation 65 Pitts Station Road Marion, North Carolina 28752-7925 for Baxter Healthcare Corporation 1 Baxter Pkwy Deerfield, IL 60015-4625. NDC 0338-0117-02
Batch or Lot Expiration Information
Lot# : C964619, C964056 and C964163, Exp 7/31/2016
