American Regent Recalls Selenious Acid Injection Due to Particulate Matter
American Regent, Inc. is recalling Selenious Acid Injection 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 agency classification is FDA Class II, and the presence of glass and particulate matter in an intravenous injection poses a significant risk of serious injury, meeting the criteria for a Severe rating.
Plain-English summary
American Regent, Inc. is recalling Selenious Acid Injection, USP, packaged in 2 mL single-dose vials. The recall involves 41,680 vials distributed nationwide within the U.S. The specific lot number is 25090, with an expiration date of 2/28/2027.
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 product is a prescription drug intended for intravenous use.
Healthcare providers and patients should stop using the affected product. Consumers should check their medication for the specific NDC numbers 0517-6502-01 or 0517-6502-10 and the lot number 25090. If the product matches these details, it should be returned to the pharmacy or healthcare provider for disposal or replacement.
The recalled product
- Product
- SELENIOUS ACID (SELENIOUS ACID)
- Brand
- SELENIOUS ACID
- Manufacturer
- American Regent, Inc.
- Category
- Drug — Injection
- Affected units
- 41,680
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 #: 25090
- Exp. Date 2/28/2027.
UPCs (1)
- 0305176502106
Distribution
Distributed nationwide across the United States.
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