⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

SOMERSET THERAPEUTICS LLC: 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

DrugsSource: FDA (drug) · Date: 2025-12-24

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
SOMERSET THERAPEUTICS LLC
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 / hazard
Subpotent product:out of specification assay results observed during long term stability testing.
Classification
Class III
Status
Ongoing
Distribution / sold at
Nationwide in the USA
Recall initiated
2025-11-26
Code info
Lot#: A250043, EXP Date 06/30/2026
Product quantity
71,310 10mL vials
Voluntary mandated
Voluntary: Firm initiated
City
Somerset
State
NJ
Country
United States
Event id
98063
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