Recall D-0238-2026

US Class III Ongoing · initiated 2025-11-26

Recalling firm

SOMERSET THERAPEUTICS LLC, NJ

Product

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.

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