FDA recall D-1057-2014

Baxter Healthcare Corp. · Class I · 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

Reason for recall

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

Distribution

Nationwide, Saudi Arabia and Colombia

Key facts

Status
Terminated
Initiation date
2013-11-18
Report date
2014-02-12
Termination date
2014-09-15
Voluntary/Mandated
Voluntary: Firm initiated
Location
Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1057-2014