Haloperidol Decanoate Injection 100mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerse...
FDA Recall #D-0357-2025 — Class II — March 21, 2025
Product Description
Haloperidol Decanoate Injection 100mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset Therapeutics Limited, Kamataka, India, Manufactured for: BluePoint Laboratories NDC 68001-581-41 (individual carton) and NDC 68001-581-48 (5x1 mL cartons)
Reason for Recall
Lack of Assurance of Sterility: Media fill with bacterial contamination
Recalling Firm
Somerset Therapeutics Private Limited — Bengaluru, N/A
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
23,960 vials
Distribution
U.S. Nationwide
Code Information
NDC 68001-581-41; A240482A, exp. date 08/2026; NDC 68001-581-48; A240482B, exp. date 08/2026
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated