CLASS I Drug recall · Reported 12 Feb 2014 · FDA Enforcement Report
50 mg Nitroglycerin in 5% Dextrose Injection (200 mcg/mL) recalled
Baxter Healthcare is recalling 50 mg Nitroglycerin in 5% Dextrose Injection (200 mcg/mL), Baxter Healthcare Corp, distributed nationwide in the US. The recall was initiated on 18 Nov 2013 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1057-2014
- FDA event ID
- 66880
- Recalling firm
- Baxter Healthcare, Deerfield, IL
- Manufacturer
- Baxter Healthcare Company
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 18 Nov 2013
- FDA classified
- 31 Jan 2014
- Reported
- 12 Feb 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 18 Nov 2013 | Recall initiated by company | |
| 31 Jan 2014 | Classified by FDA | +74 days |
| 12 Feb 2014 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Particulate Matter; particulate matter in one vial identified as silicone rubber and EPDM rubber from the vial stopper.
Product as listed by the FDA
50 mg Nitroglycerin in 5% Dextrose Injection (200 mcg/mL), 250 mL glass containers, Baxter Healthcare Corp., Deerfield, IL --- NDC 0338-1049-02
Where it was distributed
Nationwide, Saudi Arabia and Colombia
Questions about this recall
Why was it recalled?
Presence of Particulate Matter; particulate matter in one vial identified as silicone rubber and EPDM rubber from the vial stopper.
Which lots are affected?
G105197, Exp. 02/14
Where was it sold?
Nationwide, Saudi Arabia and Colombia
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Nitroglycerin recalls
All 13| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Nitroglycerin injection, USP, 50 mg/ (5 mg/mL) recalledNitroglycerin | American Regent | Particulate Matter | Nationwide |
| Drug | CLASS II | Nitroglycerin Sublingual Tablets 0.3MG recalledNitroglycerin | Glenmark Pharmaceuticals Inc., USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Nitroglycerin Sublingual Tablets 0.4MG recalledNitroglycerin | Glenmark Pharmaceuticals Inc., USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Nitroglycerin Lingual Spray, 400 mcg per spray, 200 metered sprays recalledNitroglycerin Lingual | Padagis US | Other | Nationwide |
| Drug | CLASS II | Rectiv (nitroglycerin) Ointment 0.4% For Intra-anal Use Only recalledRectiv | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |