AuroMedics Pharma LLC recalls Fondaparinux Sodium Injection, USP, 7.5 mg per 0.6 mL, Single Dose, Prefilled Syringe, Distributed by: AuroMedics Pharm…
- Recall date
- September 30, 2022
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0020-2023
- FDA classification
- Class II
- Brand / firm
- AuroMedics Pharma LLC
- Sold / distributed
- Nationwide in the USA
Why it was recalled
Subpotent Drug: Out of specification for assay
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What 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)
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