Class II Recall

Somerset Therapeutics Private Limited

Product
Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset Therapeutics Limited, Kamataka India, Manufactured for: BluePoint Laboratories NDC 68001-580-41
Reason
Lack of Assurance of Sterility: Media fill with bacterial contamination
Classification
Class II
Status
Ongoing
Lot
A240467B, exp. date 07/2026
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.