Recalls / Class III
Class IIID-0238-2026
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.
- Brand name
- Cisatracurium Besylate
- Generic name
- Cisatracurium Besylate
- Active ingredient
- Cisatracurium Besylate
- Route
- Intravenous
- NDC
- 70069-161
- FDA application
- ANDA209132
- Affected lot / code info
- Lot#: A250043, EXP Date 06/30/2026
Why it was recalled
Subpotent product:out of specification assay results observed during long term stability testing.
Recalling firm
- Firm
- SOMERSET THERAPEUTICS LLC
- Manufacturer
- Somerset Therapeutics, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 300 Franklin Square Dr, Somerset, New Jersey 08873-4187
Distribution
- Quantity
- 71,310 10mL vials
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2025-11-26
- FDA classified
- 2025-12-15
- Posted by FDA
- 2025-12-24
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0238-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.