Haloperidol Decanoate Injection, 100 mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured for: Some...
FDA Recall #D-0358-2025 — Class II — March 21, 2025
Product Description
Haloperidol Decanoate Injection, 100 mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Somerset, NJ 08873, NDC 70069-383-10
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
240 vials
Distribution
U.S. Nationwide
Code Information
A240482D, exp. date 08/2026
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated