Class II
Ongoing
Haloperidol Lactate Injection, 5 mg/mL, 25 x 1 mL Single-Dose Vials, Sterile, Rx only, For Intramuscular Use Only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26605. NDC: 67457-426-12 with Safecor Health LLC KITCHECK RFID Tag attached with incorrect serial numbers: KITCHECK 8001-03A3,00000000,003A-2560, and 8001-03A3,00000000,003A-2D3B.
This recall is currently active, issued December 10, 2025. It was issued by Safecor Health, Llc.
- Company
- Safecor Health, Llc
- Recall Initiated
- October 10, 2025
- Posted
- December 10, 2025
- Recall Number
- D-0214-2026
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 800 1mL vials
- Firm Location
- Woburn, MA, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Labeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm.
Distribution
Distributed in Massachusetts
Lot / Code Info
Lot 25381993 and 25391516, Exp 12/31/2026
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