Drug product
Fondaparinux Sodium Injection, USP, 7.5 mg per 0.6 mL, Single Dose, Prefilled Syringe, Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520. Made in India. NDC 55150-232-10 (carton)NDC 55150-232-00 (syringe)
D-0020-2023
Product summary
- Event
- Event 90925
- Status
- Terminated
- Classification
- Class II
- Quantity
- 11,520 units
- Official record key
drug-enforcement:D-0020-2023
Official wording
Reason: Subpotent Drug: Out of specification for assay
Code information: Lot # CFN200020, EXP Nov. 2022
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Subpotent