Published recall report · GlassUpdated · 1 month ago
American Regent, Inc. recall: Tralement (trace elements injection 4*, USP), packaged in a) 1mL Single Dose vials (NDC 0517-9305-01) and b) 5x1mL Single Dose vials (NDC 0517-9305-25), Rx only, AMERICAN REGENT, INC., SHIRLEY, NY 11967.
Tralement (trace elements injection 4*, USP), packaged in a) 1mL Single Dose vials (NDC 0517-9305-01) and b) 5x1mL Single Dose vials (NDC 0517-9305-25), Rx only, AMERICAN REGENT, INC., SHIRLEY, NY 11967.
Current recall status is unverified. FDA does not update drug-enforcement status after publication. Check the latest official information or ask a pharmacist.
What to do
Check the lot number on your pack against this recall and follow the firm's instructions. Do not stop taking a prescribed medicine without talking to a pharmacist or doctor first.
FDA public enforcement report, opens in a new tabWhich products
Tralement (trace elements injection 4*, USP), packaged in a) 1mL Single Dose vials (NDC 0517-9305-01) and b) 5x1mL Single Dose vials (NDC 0517-9305-25), Rx only, AMERICAN REGENT, INC., SHIRLEY, NY 11967.
- Producer
- American Regent, Inc.
- Brand
- TRALEMENT
25149
- Dates on pack
- Lot #: 25149, Exp. Date: 04/30/2027; 25371, Exp. Date: 09/30/2027.
0305178201250
More detail
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
In the news
Reporting from news publishers. Follow the official notice for product advice.
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