Papaverine HCl Injection, USP, 60 mg/2 mL (30 mg/mL), packaged in a) 2mL Single-Dose Vial (NDC 0517-4002-01), and b) 25x2mL Single-Dose Via…
American Regent, Inc. · Presence of Particulate Matter: Product contaminated with particulate matter identified as glass and/or paraformaldehyde
- Status
- Ongoing
- City
- Shirley
- State
- NY
- Country
- United States
- Classification
- Class I
- 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-0800-2026
- Product quantity
- 86,100 vials
- Reason for recall
- Presence of Particulate Matter: Product contaminated with particulate matter identified as glass and/or paraformaldehyde
- Recall initiation date
- 20260724
- Center classification date
- 20260826
- Report date
- 20260826
- Code info
- Lot #: 25202, Exp. Date: 11/30/2026.
- Product description
Papaverine HCl Injection, USP, 60 mg/2 mL (30 mg/mL), packaged in a) 2mL Single-Dose Vial (NDC 0517-4002-01), and b) 25x2mL Single-Dose Vials (NDC 0517-4002-25), Rx Only, AMERICAN REGENT, INC., SHIRLEY, NY 11967.
- Harmonized identifiers (openFDA)
- Brand name
- PAPAVERINE HYDROCHLORIDE
- Generic name
- PAPAVERINE HYDROCHLORIDE
- Manufacturer name
- American Regent, Inc.
- Product NDC
- 0517-4002
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- INTRAVENOUS
- Substance name
- PAPAVERINE HYDROCHLORIDE
- RxCUI
- 1789947
- SPL ID
- 402161da-fe45-4b0f-a5ca-a230593cc434
- SPL set ID
- 9e5e2ce4-7a57-4c61-a826-64c8d11d038e
- Package NDC
- 0517-4002-01, 0517-4002-25
- Is original packager
- true
- Upc
- 0305174002257
- UNII
- 23473EC6BQ