Drug product
Cisatracurium Besylate Injection USP, 10 mg/5 mL* (2mg/mL), 10 x 5 mL Single-dose Vials per Carton, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India, Single-dose 5 mL vial NDC 70069-141-01; 10x5 mL single dose vial per Carton NDC 70069-141-10.
D-0236-2026
Product summary
- Event
- Event 98063
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 52,340 5mL vials
- Official record key
drug-enforcement:D-0236-2026
Official wording
Reason: Subpotent product:out of specification assay results observed during long term stability testing.
Code information: Lot#: A240438, Exp Date 1/31/26, A250125, Exp Date 8/31/26
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Subpotent