Drug Recall: 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,
SOMERSET THERAPEUTICS LLC · April 24, 2024
Reason for Recall
Presence of Foreign Substance: This oil based product may contain trace amounts of water for injection (WFI).
Product Description
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.
Distribution
Nationwide within the United States
States Affected
NATIONWIDE
Quantity Affected
5,578 units
Source: FDA (openFDA Drug Enforcement)
Recall number: D-0506-2024
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.