Recall D-0358-2025

US Class II Ongoing · initiated 2025-03-21

Recalling firm

Somerset Therapeutics Private Limited

Product

Haloperidol Decanoate Injection, 100 mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Somerset, NJ 08873, NDC 70069-383-10

Reason for recall

Lack of Assurance of Sterility: Media fill with bacterial contamination

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