American Regent Recalls Papaverine Hydrochloride Injection Due to Particulate Matter
American Regent, Inc. is recalling Papaverine Hydrochloride Injection due to the presence of glass and/or paraformaldehyde particulate matter.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.
Plain-English summary
American Regent, Inc. is recalling 86,100 vials of Papaverine Hydrochloride Injection, USP, 60 mg/2 mL (30 mg/mL). The product is packaged in 2 mL single-dose vials (NDC 0517-4002-01) and 25x2 mL single-dose vials (NDC 0517-4002-25). The affected lot number is 25202, with an expiration date of 11/30/2026. The product was distributed nationwide within the U.S.
The recall was initiated because the product was found to be contaminated with particulate matter identified as glass and/or paraformaldehyde. This is a prescription-only medication intended for intravenous use.
Healthcare providers and patients should discontinue use of the affected lot and contact American Regent, Inc. for further instructions or returns.
The recalled product
- Product
- PAPAVERINE HYDROCHLORIDE (PAPAVERINE HYDROCHLORIDE)
- Brand
- PAPAVERINE HYDROCHLORIDE
- Manufacturer
- American Regent, Inc.
- Category
- Drug — Injection
- Affected units
- 86,100
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 #: 25202
- Exp. Date: 11/30/2026.
UPCs (1)
- 0305174002257
Distribution
Distributed nationwide across the United States.
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