Haloperidol decanoate Injection 50mg/mL recall — Class II (D-0506-2024) · pharmaranks
Class IIOngoing
Haloperidol decanoate Injection 50mg/mL recall
FDA recall D-0506-2024 · initiated Apr 24, 2024
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Presence of Foreign Substance: This oil based product may contain trace amounts of water for injection (WFI).
Details
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.
What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.