Nitroglycerin In Dextrose Injection
FDA Recall NDC 0338-1049
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Nitroglycerin In Dextrose (NDC 0338-1049). A significant event, classified as Class I, was initiated on Nov 18, 2013 by Baxter Healthcare Company. The reported reason for this action was: "Presence of Particulate Matter; particulate matter in one vial identified as silicone rubber and EPDM rubber from the vial stopper."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
November 2013 Class I Recall: Presence of Particulate Matter; particulate matter in one vial identified as silicone rubber and EPDM rubber from the vial stopper.
Recall Number
Class I Terminated
Presence of Particulate Matter; particulate matter in one vial identified as silicone rubber and EPDM rubber from the vial stopper.
Nov 18, 2013
Feb 12, 2014
49,932 glass containers
Recall Profile & Regulatory Data
Event ID
66880
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Baxter Healthcare Corp.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide, Saudi Arabia and Colombia
Termination Date
Sep 15, 2014
Product Description
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
0338-1047-02Product
0338-1049-02Product
0338-1051-02Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
