Drug product
50 mg Nitroglycerin in 5% Dextrose Injection (200 mcg/mL), 250 mL glass containers, Baxter Healthcare Corp., Deerfield, IL --- NDC 0338-1049-02
D-1057-2014
Product summary
- Event
- Event 66880
- Status
- Terminated
- Classification
- Class I
- Quantity
- 49,932 glass containers
- Official record key
drug-enforcement:D-1057-2014
Official wording
Reason: Presence of Particulate Matter; particulate matter in one vial identified as silicone rubber and EPDM rubber from the vial stopper.
Code information: G105197, Exp. 02/14
Distribution pattern: Nationwide, Saudi Arabia and Colombia
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter