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
Presence of Foreign Substance: This oil based product may contain trace amounts of water for injection (WFI).
Classification
Class II
Status
Ongoing
Lot
Lot #: a) A230412A, Exp. Date 07/2025; b)A230412B, Exp. Date 07/2025
Date
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