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)
Reported: November 2, 2022 Initiated: September 30, 2022 #D-0020-2023
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)
Reason for Recall
Subpotent Drug: Out of specification for assay
Details
- Recalling Firm
- AuroMedics Pharma LLC
- Units Affected
- 11,520 units
- Distribution
- Nationwide in the USA
- Location
- East Windsor, NJ
Frequently Asked Questions
What product was recalled? ▼
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). Recalled by AuroMedics Pharma LLC. Units affected: 11,520 units.
Why was this product recalled? ▼
Subpotent Drug: Out of specification for assay
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 2, 2022. Severity: Moderate. Recall number: D-0020-2023.
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