SOMERSET THERAPEUTICS LLC recalls Haloperidol decanoate Injection 50mg/mL, packaged in a) 1 mL Single-Dose Vials (NDC 70069-381-01) and b) 10 1mL Single-D
Recalled May 29, 2024 · FDA recall D-0506-2024 · SOMERSET THERAPEUTICS
Hazard
Presence of Foreign Substance: This oil based product may contain trace amounts of water for injection (WFI). · FDA Class II
Units
5,578 units
Sold at
Nationwide within the United States
Description
Presence of Foreign Substance: This oil based product may contain trace amounts of water for injection (WFI).
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.
Manufacturer(s)
SOMERSET THERAPEUTICS LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →