Recall D-0355-2025

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 for: Somerset Therapeutics, LLC, Somerset, NJ 08873, NDC 70069-381-01 (individual carton) and NDC 70069-381-10 (10x1 mL carton)

Reason for recall

Lack of Assurance of Sterility: Media fill with bacterial contamination

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