Drug 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.
D-0237-2026
Product summary
- Event
- Event 98063
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 28,660 20mL vials
- Official record key
drug-enforcement:D-0237-2026
Official wording
Reason: Subpotent product:out of specification assay results observed during long term stability testing.
Code information: Lot #: A250020, Exp Date 06/30/2026
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Subpotent