Product: AstrinGyn (Ferric Subsulfate) Aqueous, 259 mg/g, 8 gm Single Use Vials, Manufactured for CooperSurgical, Trumbull, CT 06611, NDC 59365-6065-0, Ref 6065.
Reason for recall: CGMP Deviations: Products not manufactured under current good manufacturing practices.
Recall initiated: 20230809
Status: Completed
Classification: Class II
Recall type: Voluntary: Firm initiated