D-0214-2026Class II

Safecor Health, LLC

Recalling firm

Safecor Health, LLC

Product type

Drug

Status

Ongoing

Report date

2025-12-10

Distribution

Distributed in Massachusetts

Firm state

Product quantity

800 1mL vials

Initiated by

Voluntary: Firm initiated

SPEQ quality domain

Documentation & Change Control

Reason for recall

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

Product description

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.

Code / lot info

Lot 25381993 and 25391516, Exp 12/31/2026

Other recalls SPEQ maps to Documentation & Change Control

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See all Documentation & Change Control recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.