Fondaparinux Sodium Injection recall: Subpotent
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)
Why was Fondaparinux Sodium Injection recalled?
Subpotent Drug: Out of specification for assay
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot # CFN200020, EXP Nov. 2022
- 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)
- Recalling firm
- AuroMedics Pharma LLC
- Quantity
- 11,520 units
- Distribution
- Nationwide in the USA
- Recall date
- November 2, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)