Safecor Health, LLC: Haloperidol Lactate Injection, 5 mg/mL, 25 x 1 mL Single-Dose Vials, Sterile, Rx only, For Intramuscular Use Only, Manufactured for: Mylan
Read the official notice at FDA (drug) →
The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.
- Company / brand
- Safecor Health, LLC
- Product
- 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.
- Reason / hazard
- Labeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- Distributed in Massachusetts
- Recall initiated
- 2025-10-10
- Code info
- Lot 25381993 and 25391516, Exp 12/31/2026
- Product quantity
- 800 1mL vials
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Woburn
- State
- MA
- Country
- United States
- Event id
- 97977
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