Data Composite

Recall D-0369-2025

US Class II Ongoing · initiated 2025-04-02

Recalling firm

Amerisource Health Services LLC, OH

Product

Haloperidol Decanoate Injection, 100mg/mL*, 5 x 1 mL Single-Dose Vials, Rx Only, Manufactured by: Somerset Therapeutics Limited, #54/1 Boodhihal Village, Nelamangala, Bangalore -562123, Karnataka, India, Manufactured for: BluePoint Laboratories, NDC 68001-581-48.

Reason for recall

Lack of assurance of sterility. Bacterial contamination detected in some media fill units

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