Drug 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.
D-0238-2026
Product summary
- Event
- Event 98063
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 71,310 10mL vials
- Official record key
drug-enforcement:D-0238-2026
Official wording
Reason: Subpotent product:out of specification assay results observed during long term stability testing.
Code information: Lot#: A250043, EXP Date 06/30/2026
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Subpotent