Recall D-0357-2025

US Class II Ongoing · initiated 2025-03-21

Recalling firm

Somerset Therapeutics Private Limited

Product

Haloperidol Decanoate Injection 100mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset Therapeutics Limited, Kamataka, India, Manufactured for: BluePoint Laboratories NDC 68001-581-41 (individual carton) and NDC 68001-581-48 (5x1 mL cartons)

Reason for recall

Lack of Assurance of Sterility: Media fill with bacterial contamination

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