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
Recall initiated: 20250321
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated