FDA recall D-0506-2024

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 for recall

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

Distribution

Nationwide within the United States

Key facts

Status

Ongoing

Initiation date

2024-04-24

Report date

2024-05-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Somerset, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0506-2024