Recall: D-0506-2024

Class II - Potentially Harmful

Class IIClassification

2024-04-24Initiated

OngoingStatus

SOMERSET THERAPEUTICS LLCFirm

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.

Reason

Presence of Foreign Substance: This oil based product may contain trace amounts of water for injection (WFI).

Distribution

Nationwide within the United States

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.