FDA-Drug2022-11-02Class II
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)
AuroMedics Pharma LLC
Hazard
Subpotent Drug: Out of specification for assay
Sold states
Nationwide in the USA
Affected count
11,520 units
Manufactured in
279 Princeton Hightstown Rd, N/A, East Windsor, NJ, United States
Products
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)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0020-2023Don't want to check this manually?
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