Product: Haloperidol decanoate Injection 50mg/mL, packaged in a) 1 mL Single-Dose Vials (NDC 70069-381-01) and b) 10 1mL Single-Dose Vials (NDC 70069-381-10), Rx only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India.
Reason for recall: Presence of Foreign Substance: This oil based product may contain trace amounts of water for injection (WFI).
Recall initiated: 20240424
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated