FDA recall D-0367-2025

Amerisource Health Services LLC · Class II · drug

Product

Haloperidol Decanoate Injection, 50mg/mL* , 1 mL Single-Dose Vial, Rx only, Manufactured by Somerset Therapeutics Limited, 54/1, Boodhihal Village, Nelamangala, Bangalore - 562123, Karnataka, India, Manufactured for: BluePoint Laboratories, NDC 68001-580-41.

Reason for recall

Lack of assurance of sterility. Bacterial contamination detected in some media fill units

Distribution

Nationwide in the USA

Key facts

Status: Ongoing
Initiation date: 2025-04-02
Report date: 2025-04-30
Voluntary/Mandated: Voluntary: Firm initiated
Location: Columbus, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0367-2025