FDA recall D-0358-2025

Somerset Therapeutics Private Limited · Class II · drug

Product

Haloperidol Decanoate Injection, 100 mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Somerset, NJ 08873, NDC 70069-383-10

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-0358-2025