Haloperidol Decanoate Injection, 100 mg/mL*, 1 x 1 mL Single-Dose Vial, Rx only, Manufactured by...
FDA Recall #D-0368-2025 — Class II — April 2, 2025
Product Description
Haloperidol Decanoate Injection, 100 mg/mL*, 1 x 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 68001-581-41.
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
14,189 vials
Distribution
Nationwide in the USA
Code Information
A240482A, EXP 08/31/2026
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated