FDAHealthNovember 26, 2025
SOMERSET THERAPEUTICS LLC — Cisatracurium Besylate Injection USP, 200mg/20mL*(10mg/mL), 10 x 20 mL Single-dose Vials per Carton, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33
⚠️ Subpotent product:out of specification assay results observed during long term stability testing.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- November 26, 2025
Nationwide in the USA
What's affected?
- Product
- Cisatracurium Besylate Injection USP, 200mg/20mL*(10mg/mL), 10 x 20 mL Single-dose Vials per Carton, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India, Single dose 20mL vial NDC 70069-151-01; 10 x 20 Single dose vials per Carton, NDC 70069-151-10.
- UPC
- 0370069141014
- Lot code
- A250020
Additional details
Lot #: A250020, Exp Date 06/30/2026
What should I do?
Recommended action
Class III recall. Voluntary: Firm initiated Quantity affected: 28,660 20mL vials.
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