Ecometics, Inc. recalls AstrinGyn (Ferric Subsulfate) Aqueous, 259 mg/g, 8 gm Single Use Vials, Manufactured for CooperSurgical, Trumbull, CT 06
Recalled August 30, 2023 · FDA recall D-1101-2023 · Ecometics
Hazard
CGMP Deviations: Products not manufactured under current good manufacturing practices. · FDA Class II
Units
92,967 vials
Sold at
Nationwide in the USA
Description
CGMP Deviations: Products not manufactured under current good manufacturing practices.
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.
Manufacturer(s)
Ecometics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →