Nitroglycerin injection, USP, 50 mg/10 mL (5 mg/mL), packaged in a) 10 mL vials (NDC 0517-4810-01), b) 25x10mL vials (NDC 0517-4810-25) RX…
American Regent, Inc. · Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
- Status
- Ongoing
- City
- Shirley
- State
- NY
- Country
- United States
- Classification
- Class II
- Product type
- Drugs
- Event ID
- 99503
- Recalling firm
- American Regent, Inc.
- Address 1
- 5 Ramsay Rd
- Postal code
- 11967-4701
- Voluntary mandated
- Voluntary: Firm initiated
- Initial firm notification
- Press Release
- Distribution pattern
- Nationwide within the U.S
- Recall number
- D-0791-2026
- Product quantity
- 98,200 vials
- Reason for recall
- Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
- Recall initiation date
- 20260724
- Center classification date
- 20260826
- Report date
- 20260826
- Code info
- Lot #: 24291, Exp. Date: 8/31/2026
- Product description
Nitroglycerin injection, USP, 50 mg/10 mL (5 mg/mL), packaged in a) 10 mL vials (NDC 0517-4810-01), b) 25x10mL vials (NDC 0517-4810-25) RX only, AMERICAN REGENT, INC., Shirley, NY 11967.
- Harmonized identifiers (openFDA)
- Application number
- ANDA072034
- Brand name
- NITROGLYCERIN
- Generic name
- NITROGLYCERIN
- Manufacturer name
- American Regent, Inc.
- Product NDC
- 0517-4810
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- INTRAVENOUS
- Substance name
- NITROGLYCERIN
- RxCUI
- 237205
- SPL ID
- ee83c8b9-c31a-4f32-9e9d-0370545204cb
- SPL set ID
- 8c52cdf6-87be-4719-b105-f08be096d462
- Package NDC
- 0517-4810-01, 0517-4810-25
- Is original packager
- true
- Upc
- 0305174810258
- Nui
- N0000175415, M0014874, N0000009909
- Pharm class epc
- Nitrate Vasodilator [EPC]
- Pharm class cs
- Nitrates [CS]
- Pharm class pe
- Vasodilation [PE]
- UNII
- G59M7S0WS3