Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured for: Somerse...
FDA Recall #D-0355-2025 — Class II — March 21, 2025
Product Description
Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Somerset, NJ 08873, NDC 70069-381-01 (individual carton) and NDC 70069-381-10 (10x1 mL carton)
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
997 vials
Distribution
U.S. Nationwide
Code Information
NDC 70069-381-01; A240467A, exp. date 07/2026; NDC 70069-381-10; A240467C, exp. date 07/2026
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated