Data Composite

Recall D-0367-2025

US Class II Ongoing · initiated 2025-04-02

Recalling firm

Amerisource Health Services LLC, OH

Product

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

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