Recall: D-0238-2026

Class III - Minor Violations

Class IIIClassification

2025-11-26Initiated

OngoingStatus

SOMERSET THERAPEUTICS LLCFirm

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

Subpotent product:out of specification assay results observed during long term stability testing.

Distribution

Nationwide in the USA

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.