Cisatracurium Besylate Injection USP, 200mg/20mL*(10mg/mL), 10 x 20 mL Single-dose Vials per Cart...
FDA Recall #D-0237-2026 — Class III — November 26, 2025
Product Description
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.
Recalling Firm
SOMERSET THERAPEUTICS LLC — Somerset, NJ
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
28,660 20mL vials
Distribution
Nationwide in the USA
Code Information
Lot #: A250020, Exp Date 06/30/2026
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated