November 2013 FDA Recall Nitroglycerin In Dextrose by Baxter Healthcare Corp.
D-1057-2014 - Presence of Particulate Matter; particulate matter in one vial identified as silicone rubber and EPDM rubber from the vial stopper.

This Class I drug recall was voluntarily initiated by Baxter Healthcare Corp. on November 18, 2013 for the product Nitroglycerin In Dextrose. The FDA reported the reason for recall as presence of particulate matter; particulate matter in one vial identified as silicone rubber and epdm rubber from the vial stopper.. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1057-2014

Reason for Recall
Presence of Particulate Matter; particulate matter in one vial identified as silicone rubber and EPDM rubber from the vial stopper.
Initiated
11-18-2013
Reported
02-12-2014
Quantity
49,932 glass containers

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
66880
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
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.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide, Saudi Arabia and Colombia
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-15-2014
Product Description About Product Description
Full technical description of the product.
50 mg Nitroglycerin in 5% Dextrose Injection (200 mcg/mL), 250 mL glass containers, Baxter Healthcare Corp., Deerfield, IL --- NDC 0338-1049-02

Batch or Lot Expiration Information

Lot# G105197, Exp. 02/14

Affected Packages Involved in this Recall

0338-1047-02 Nitroglycerin In Dextrose
0338-1049-02 Nitroglycerin In Dextrose
0338-1051-02 Nitroglycerin In Dextrose