Haloperidol Decanoate Injection, 50mg/mL* , 1 mL Single-Dose Vial, Rx only, Manufactured by Somer...
FDA Recall #D-0367-2025 — Class II — April 2, 2025
Product Description
Haloperidol Decanoate Injection, 50mg/mL* , 1 mL Single-Dose Vial, Rx only, Manufactured by Somerset Therapeutics Limited, 54/1, Boodhihal Village, Nelamangala, Bangalore - 562123, Karnataka, India, Manufactured for: BluePoint Laboratories, NDC 68001-580-41.
Reason for Recall
Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Recalling Firm
Amerisource Health Services LLC — Columbus, OH
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
2,110 vials
Distribution
Nationwide in the USA
Code Information
A240467B, EXP 07/31/2026
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated