American Regent Recalls Tralement Injection Due to Particulate Matter
American Regent is recalling 323,000 vials of Tralement (trace elements injection 4) 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 the presence of glass and particulate matter in an intravenous injection presents a significant risk of serious injury, meeting the criteria for a Severe rating.
Plain-English summary
American Regent, Inc. is recalling 323,000 vials of Tralement (trace elements injection 4, USP), a prescription-only intravenous medication. The product is packaged in 1mL single-dose vials (NDC 0517-9305-01) and 5x1mL single-dose vials (NDC 0517-9305-25). The recall is limited to Lot #25149 (Exp. 04/30/2027) and Lot #25371 (Exp. 09/30/2027).
The recall was initiated because the product was found to be contaminated with particulate matter identified as hair, glass, and/or paraformaldehyde. The affected units were distributed nationwide within the United States.
Healthcare providers and patients should stop using the recalled vials and contact American Regent, Inc. for further instructions or replacement. Consumers should verify the lot number and expiration date on their vials to determine if they are affected.
The recalled product
- Product
- TRALEMENT (TRACE ELEMENTS INJECTION 4)
- Brand
- TRALEMENT
- Manufacturer
- American Regent, Inc.
- Category
- Drug — Prescription Injection
- Affected units
- 323,000
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 (4)
- Lot #: 25149
- Exp. Date: 04/30/2027
- 25371
- Exp. Date: 09/30/2027.
UPCs (1)
- 0305178201250
Distribution
Distributed nationwide across the United States.
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