FDA recall D-0237-2026

Product

Cisatracurium Besylate Injection USP, 200mg/20mL*(10mg/mL), 10 x 20 mL Single-dose Vials per Carton, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India, Single dose 20mL vial NDC 70069-151-01; 10 x 20 Single dose vials per Carton, NDC 70069-151-10.

Reason for recall

Subpotent product:out of specification assay results observed during long term stability testing.

Distribution

Nationwide in the USA

Key facts

Status

Ongoing

Initiation date

2025-11-26

Report date

2025-12-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Somerset, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0237-2026