American Regent Recalls Nitroglycerin Injection Due to Particulate Matter
American Regent, Inc. is recalling Nitroglycerin injection vials due to the presence of particulate matter, including hair, glass, and paraformaldehyde.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves the presence of particulate matter (glass, hair, paraformaldehyde) in an injectable drug, which poses a significant risk of injury or adverse health consequences, meeting the criteria for a Severe rating.
Plain-English summary
American Regent, Inc. is recalling Nitroglycerin injection, USP, 50 mg/10 mL (5 mg/mL). The recall affects 98,200 vials distributed nationwide within the U.S. The specific lot number is 24291, with an expiration date of 8/31/2026. The product is available in 10 mL vials (NDC 0517-4810-01) and 25x10mL vials (NDC 0517-4810-25).
The recall was initiated because the product was found to be contaminated with particulate matter. The identified contaminants include hair, glass, and/or paraformaldehyde. This is an FDA Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Healthcare providers and patients should stop using the affected Nitroglycerin injection vials immediately. Consumers should check their medication for the specific lot number and expiration date listed above. If the product matches the recalled lot, it should be returned to the pharmacy or the manufacturer for disposal or replacement.
The recalled product
- Product
- NITROGLYCERIN (NITROGLYCERIN)
- Brand
- NITROGLYCERIN
- Manufacturer
- American Regent, Inc.
- Category
- Drug — Injection
- Affected units
- 98,200
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 24291
- Exp. Date: 8/31/2026
UPCs (1)
- 0305174810258
Distribution
Distributed nationwide across the United States.
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