Multrys (Trace Elements Injection 4, USP), For intravenous infusion, packaged in a) 1 mL Single-Dose Vial (NDC 0517-9302-01), and b) 25x1 m…
American Regent, Inc. · Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
- Status
- Ongoing
- City
- Shirley
- State
- NY
- Country
- United States
- Classification
- Class II
- 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-0799-2026
- Product quantity
- 185,775 vials
- Reason for recall
- Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
- Recall initiation date
- 20260724
- Center classification date
- 20260826
- Report date
- 20260826
- Code info
- Lot #: 25163, Exp. Date: 4/30/2027.
- Product description
Multrys (Trace Elements Injection 4, USP), For intravenous infusion, packaged in a) 1 mL Single-Dose Vial (NDC 0517-9302-01), and b) 25x1 mL Single-Dose Vials (NDC 0517-9302-25) Rx Only, AMERICAN REGENT, INC., SHIRLEY, NY 11967.
- Harmonized identifiers (openFDA)
- Application number
- NDA209376
- Brand name
- MULTRYS
- Generic name
- TRACE ELEMENTS INJECTION 4
- Manufacturer name
- American Regent, Inc.
- Product NDC
- 0517-9302
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- INTRAVENOUS
- Substance name
- ZINC SULFATE, CUPRIC SULFATE, MANGANESE SULFATE, SELENIOUS ACID
- RxCUI
- 2568573, 2568579
- SPL ID
- 5c07b457-1143-440c-9975-90c16852a103
- SPL set ID
- 995f1efa-aca0-4b6c-9099-f8e757c2133a
- Package NDC
- 0517-9302-01, 0517-9302-25
- Is original packager
- true
- Upc
- 0305178201250
- UNII
- 89DS0H96TB, LRX7AJ16DT, W00LYS4T26, F6A27P4Q4R