Class II · Moderate risk
Nitroglycerin injection
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Nitroglycerin Lingual Spray
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Defective Delivery System
Cause type: Packaging defect
Failed child-resistant closures, leaks, cracked containers, or a defective delivery device. Packaging failures risk accidental exposure (especially to children) or product contamination. All packaging defect recalls.
What was recalled
Nitroglycerin Lingual Spray, 400 mcg per spray, 200 metered sprays, 12 g bottles, Rx only, Manufactured by Perrigo, Yeruham, Israel; Distributed by Perrigo, Allegan, MI 49010, NDC 45802-210-02
Affected NDC
45802-0210-02
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 lingual Nitroglycerin NDC 45802-0210 |
400 ug/1 | Spray Oral |
Padagis Israel Pharmaceuticals Ltd | Rx |
- Recalling firm
- Padagis US LLC
- NDC code
- 45802-210-02
- Origin
- MN, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0372-2022 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. 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
Rectiv (nitroglycerin)
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Other recalls by Padagis US LLC
All 2021 recalls
Class II · Moderate risk
Nystatin Cream USP
Subpotent Drug: Low out of specification assay results performed during long-term stability testing.
Class II · Moderate risk
Estradiol Gel
Defective Container: Some packets may not be fully sealed, potentially allowing for loss of Ethanol from the product.
Class III · Low risk
Triamcinolone Acetonide Cream USP
Subpotent and Superpotent Drug. Out of specification assay results recorded as part of Uniformity of Container test during long-term stability testing.
Class II · Moderate risk
Trospium Chloride Extended-Release Capsules
Failed Tablets/Capsules specifications; missing/broken/extra tablets within the capsules
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