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Recall Observatory FDA recall evidence

Drug 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.

D-0214-2026

October 10, 2025

Class II

Product summary

Firm
Safecor Health, LLC
Event
Event 97977
Status
Ongoing
Classification
Class II
Quantity
800 1mL vials
Official record key
drug-enforcement:D-0214-2026

Official wording

Reason: Labeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm.

Code information: Lot 25381993 and 25391516, Exp 12/31/2026

Distribution pattern: Distributed in Massachusetts

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Not Elsewhere Classified:Incorrect