50 mg Nitroglycerin in 5% Dextrose Injection — Class I drug recall D-1057-2014
Terminated recall by Baxter Healthcare Corp., reported 2014-02-12, distributed nationwide. Presence of Particulate Matter; particulate matter in one vial identified as silicone rubber and EPDM rubber f
| Recall number | D-1057-2014 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corp., Deerfield, IL, United States |
| Recall initiated | 2013-11-18 |
| Classified | 2014-01-31 |
| Reported by FDA | 2014-02-12 |
| Terminated | 2014-09-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | CO, SA |
| Quantity | 49,932 glass |
| Reason classes | specification failure |
| NDC | 00338-1047, 00338-1047-02, 00338-1049, 00338-1049-02, 00338-1051, 00338-1051-02 |
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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.