Drug recall D-0020-2023
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)
Reason for recall
Subpotent Drug: Out of specification for assay
Lots and codes
Lot # CFN200020, EXP Nov. 2022
Recall details
- Recalling firm
- AuroMedics Pharma LLC, East Windsor, NJ
- Quantity
- 11,520 units
- Distribution
- Nationwide in the USA
- Type
- Voluntary: Firm initiated
- Recall initiated
- September 30, 2022
- Terminated
- September 18, 2024
Related products
- Fondaparinux Sodium – drug information
- NDC 55150-231 Fondaparinux Sodium · Fondaparinux Sodium 5 mg/.4mL · Eugia US LLC
- NDC 55150-233 Fondaparinux Sodium · Fondaparinux Sodium 10 mg/.8mL · Eugia US LLC
- NDC 55150-232 Fondaparinux Sodium · Fondaparinux Sodium 7.5 mg/.6mL · Eugia US LLC
- NDC 55150-230 Fondaparinux Sodium · Fondaparinux Sodium 2.5 mg/.5mL · Eugia US LLC