FDA-Drug2025-12-24Class III
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.
SOMERSET THERAPEUTICS LLC
Hazard
Subpotent product:out of specification assay results observed during long term stability testing.
Sold states
Nationwide in the USA
Affected count
71,310 10mL vials
Manufactured in
300 Franklin Square Dr, Somerset, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0238-2026Don't want to check this manually?
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