FDAHealthNovember 26, 2025
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 Therapeutics, LLC, Hollywood, F
⚠️ 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, 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.
- UPC
- 0370069161012
- Lot code
- A250043
Additional details
Lot#: A250043, EXP Date 06/30/2026
What should I do?
Recommended action
Class III recall. Voluntary: Firm initiated Quantity affected: 71,310 10mL vials.
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