Information
SOMERSET THERAPEUTICS LLC Recalls Cisatracurium Besylate Injection USP
This is a Class III recall. This product is unlikely to cause adverse health reactions but violates FDA regulations.
Source: FDA
InfoRecall #D-0237-2026Drug / Pharmaceutical
SOMERSET THERAPEUTICS LLC Recalls Cisatracurium Besylate Injection USP
SOMERSET THERAPEUTICS LLC · Class III — Regulatory
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.
FDA Classification
Class III — Regulatory
A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Distribution
Nationwide in the USA
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
Sources: FDA openFDA Enforcement Database