Why it was recalled
Subpotent Drug: Out of specification for assay
Product description
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)
Lot numbers, UPCs & expiration codes
Lot # CFN200020, EXP Nov. 2022
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0020-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 30, 2022
- FDA report date
- Nov 2, 2022
- Quantity
- 11,520 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- AuroMedics Pharma LLC
Original FDA data
Every field from FDA enforcement report D-0020-2023, exactly as published.
Show all FDA fields
- City
- East Windsor
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 90925
- Address
- 279 Princeton Hightstown Rd
- Code information
- Lot # CFN200020, EXP Nov. 2022
- Postal code
- 08520-1401
- Report date
- Nov 2, 2022
- Product type
- Drugs
- Recall number
- D-0020-2023
- Classification
- Class II
- Recalling firm
- AuroMedics Pharma LLC
- Product quantity
- 11,520 units
- Termination date
- Sep 18, 2024
- Reason for recall
- Subpotent Drug: Out of specification for assay
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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)
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Sep 30, 2022
- Initial firm notification
- Letter
- Center classification date
- Oct 24, 2022