50 mg Nitroglycerin in 5% Dextrose Injection (200 mcg/mL), 250 mL glass containers, Baxter Health...
FDA Recall #D-1057-2014 — Class I — November 18, 2013
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.
Recalling Firm
Baxter Healthcare Corp. — Deerfield, IL
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
49,932 glass containers
Distribution
Nationwide, Saudi Arabia and Colombia
Code Information
G105197, Exp. 02/14
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated