FDA recall D-0357-2025

Somerset Therapeutics Private Limited · Class II · drug

Product

Haloperidol Decanoate Injection 100mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset Therapeutics Limited, Kamataka, India, Manufactured for: BluePoint Laboratories NDC 68001-581-41 (individual carton) and NDC 68001-581-48 (5x1 mL cartons)

Reason for recall

Lack of Assurance of Sterility: Media fill with bacterial contamination

Distribution

U.S. Nationwide

Key facts

Status: Ongoing
Initiation date: 2025-03-21
Report date: 2025-04-16
Voluntary/Mandated: Voluntary: Firm initiated
Location: Bengaluru, N/A, India

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0357-2025