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

Recall Number: D-0358-2025

Firm: Somerset Therapeutics Private Limited

Classification: Class II

Status: Ongoing

Report Date: 20250416

Initiation Date: 20250321

Termination Date:

Reason for Recall

Lack of Assurance of Sterility: Media fill with bacterial contamination

Product Description

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

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Data source: openFDA · Updated regularly