Recall: D-0236-2026

Class III - Minor Violations

Class IIIClassification

2025-11-26Initiated

OngoingStatus

SOMERSET THERAPEUTICS LLCFirm

Product

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

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.