AstrinGyn Aqueous recalled over manufacturing violations
- Recall date
- August 9, 2023
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Ecometics, Inc. recalls AstrinGyn (Ferric Subsulfate) Aqueous, 259 mg/g, 8 gm Single Use Vials, Manufactured for CooperSurgical, Trumbull, CT 0…
- Recall number
- D-1101-2023
- FDA classification
- Class II
- Brand / firm
- Ecometics, Inc.
- Sold / distributed
- Nationwide in the USA
Why it was recalled
CGMP Deviations: Products not manufactured under current good manufacturing practices.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
AstrinGyn (Ferric Subsulfate) Aqueous, 259 mg/g, 8 gm Single Use Vials, Manufactured for CooperSurgical, Trumbull, CT 06611, NDC 59365-6065-0, Ref 6065.
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