PlainRecalls
FDA Drug Critical Class I Terminated

50 mg Nitroglycerin in 5% Dextrose Injection (200 mcg/mL), 250 mL glass containers, Baxter Healthcare Corp., Deerfield, IL --- NDC 0338-1049-02

Reported: February 12, 2014 Initiated: November 18, 2013 #D-1057-2014

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

Reason for Recall

Presence of Particulate Matter; particulate matter in one vial identified as silicone rubber and EPDM rubber from the vial stopper.

Details

Recalling Firm
Baxter Healthcare Corp.
Units Affected
49,932 glass containers
Distribution
Nationwide, Saudi Arabia and Colombia
Location
Deerfield, IL

Frequently Asked Questions

What product was recalled?
50 mg Nitroglycerin in 5% Dextrose Injection (200 mcg/mL), 250 mL glass containers, Baxter Healthcare Corp., Deerfield, IL --- NDC 0338-1049-02. Recalled by Baxter Healthcare Corp.. Units affected: 49,932 glass containers.
Why was this product recalled?
Presence of Particulate Matter; particulate matter in one vial identified as silicone rubber and EPDM rubber from the vial stopper.
Which agency issued this recall?
This recall was issued by the FDA Drug on February 12, 2014. Severity: Critical. Recall number: D-1057-2014.