FDA-Drug2024-05-29Class II
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.
SOMERSET THERAPEUTICS LLC
Hazard
Presence of Foreign Substance: This oil based product may contain trace amounts of water for injection (WFI).
Sold states
Nationwide within the United States
Affected count
5,578 units
Manufactured in
300 Franklin Square Dr, Somerset, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0506-2024Don't want to check this manually?
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