American Regent Recalls Multrys Trace Elements Injection Due to Particulate Matter
American Regent is recalling Multrys (Trace Elements Injection 4) 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 intravenous injection, which poses a significant risk of adverse health consequences.
Plain-English summary
American Regent, Inc. is recalling 185,775 vials of Multrys (Trace Elements Injection 4, USP) for intravenous infusion. The recall affects single-dose vials (1 mL) and multi-dose packages (25x1 mL) distributed nationwide within the U.S. The specific lot number is 25163, with an expiration date of 4/30/2027.
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 is a Class II recall, indicating a situation where 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 lot of Multrys immediately. Patients who have received this specific lot of the medication should contact their healthcare provider for guidance. The recall is limited to the specific lot number and expiration date listed above.
The recalled product
- Product
- MULTRYS (TRACE ELEMENTS INJECTION 4)
- Brand
- MULTRYS
- Manufacturer
- American Regent, Inc.
- Category
- Drug — Prescription Injection
- Affected units
- 185,775
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 #: 25163
- Exp. Date: 4/30/2027.
UPCs (1)
- 0305178201250
Distribution
Distributed nationwide across the United States.
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