Recall D-0356-2025

US Class II Ongoing · initiated 2025-03-21

Recalling firm

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 for recall

Lack of Assurance of Sterility: Media fill with bacterial contamination

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