Cisatracurium Besylate Injection USP, 20 mg/10 mL*,(2 mg/mL), 10 x 10 mL Multiple-dose Vials per ...
FDA Recall #D-0238-2026 — Class III — November 26, 2025
Product Description
Cisatracurium Besylate Injection USP, 20 mg/10 mL*,(2 mg/mL), 10 x 10 mL Multiple-dose Vials per carton, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India, 10mL Multiple-dose vial, NDC 70069-161-01; 10x10mL Multiple-dose vials per Carton, NDC 70069-161-01.
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
71,310 10mL vials
Distribution
Nationwide in the USA
Code Information
Lot#: A250043, EXP Date 06/30/2026
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated