FDAFDA · Food and drugs·Recall number D-1101-2023
AstrinGyn (Ferric Subsulfate) Aqueous, 259 mg/g, 8 gm Single Use Vials, Manufactured for CooperSurgical, Trumbull, CT 06611, NDC 59365-6065-0, Ref 6065.
Published August 30, 2023 · Recall initiated: August 9, 2023
Status when published: Completed — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: Products not manufactured under current good manufacturing practices.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ecometics, Inc.
- Distributor
- Nationwide in the USA
- Lot
- Lot #: 2E144A, 2E157A, exp: 11/2023; 2E270A, exp: 3/2024; 2E300A, exp: 4/2024
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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