FDA Drug Class III — Least Serious

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.

Hazard

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

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Products

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-do
Brand
SOMERSET THERAPEUTICS LLC
UPC
Lot#: A240438, Exp Date 1/31/26, A250125, Exp Date 8/31/26

Units Affected

52,340 5mL vials

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