Class II · Moderate risk
Nitroglycerin injection
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
50 mg Nitroglycerin in 5% Dextrose Injection
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Presence of Particulate Matter; particulate matter in one vial identified as silicone rubber and EPDM rubber from the vial stopper.
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
What was recalled
50 mg Nitroglycerin in 5% Dextrose Injection (200 mcg/mL), 250 mL glass containers, Baxter Healthcare Corp., Deerfield, IL --- NDC 0338-1049-02
Affected NDC
0338-1049-02
Compare with the code on your package — it is the most precise check available.
Drug: Nitroglycerin
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Nitroglycerin In Dextrose Nitroglycerin NDC 00338-1049 |
20 mg/100mL | Injection Intravenous |
Baxter Healthcare Company | Rx |
- Recalling firm
- Baxter Healthcare Corp.
- NDC code
- 0338-1049-02
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1057-2014 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Nitroglycerin recalls
See all
Class II · Moderate risk
Nitroglycerin Sublingual Tablets 0.3MG
CGMP Deviations
Class II · Moderate risk
Nitroglycerin Sublingual Tablets 0.4MG 100-count carton
CGMP Deviations
Class II · Moderate risk
Nitrostat (Nitroglycerin Sublingual Tablets, USP)
cGMP deviations: Temperature abuse
Class II · Moderate risk
Nitroglycerin Lingual Spray
Defective Delivery System
Other recalls by Baxter Healthcare Corp.
All 2013 recalls
Class I · High risk
Dextrose Injection
Presence of Particulate Matter: particulate matter identified as stainless steel particles in the solution.
Class I · High risk
0.9% Sodium Chloride Injection USP 500 mL
Presence of particulate matter: Particulates identified as fiberglass
Class II · Moderate risk
Daptomycin
CGMP Deviations
Class II · Moderate risk
Vancomycin Injection
CGMP Deviations
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