Recalls / Class I
Class ID-1057-2014
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
50 mg Nitroglycerin in 5% Dextrose Injection (200 mcg/mL), 250 mL glass containers, Baxter Healthcare Corp., Deerfield, IL --- NDC 0338-1049-02
- Brand name
- Nitroglycerin In Dextrose
- Generic name
- Nitroglycerin
- Active ingredient
- Nitroglycerin
- Route
- Intravenous
- NDCs
- 0338-1047, 0338-1049, 0338-1051
- FDA application
- NDA019970
- Affected lot / code info
- G105197, Exp. 02/14
Why it was recalled
Presence of Particulate Matter; particulate matter in one vial identified as silicone rubber and EPDM rubber from the vial stopper.
Recalling firm
- Firm
- Baxter Healthcare Corp.
- Manufacturer
- Baxter Healthcare Company
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Baxter Pkwy, Deerfield, Illinois 60015-4625
Distribution
- Quantity
- 49,932 glass containers
- Distribution pattern
- Nationwide, Saudi Arabia and Colombia
Timeline
- Recall initiated
- 2013-11-18
- FDA classified
- 2014-01-31
- Posted by FDA
- 2014-02-12
- Terminated
- 2014-09-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1057-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.