Cisatracurium Besylate Injection USP, 10 mg/5 mL* (2mg/mL), 10 x 5 mL Single-dose Vials per Carto...
FDA Recall #D-0236-2026 — Class III — November 26, 2025
Product Description
Cisatracurium Besylate Injection USP, 10 mg/5 mL* (2mg/mL), 10 x 5 mL Single-dose Vials per Carton, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India, Single-dose 5 mL vial NDC 70069-141-01; 10x5 mL single dose vial per Carton NDC 70069-141-10.
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
52,340 5mL vials
Distribution
Nationwide in the USA
Code Information
Lot#: A240438, Exp Date 1/31/26, A250125, Exp Date 8/31/26
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated