FDA-Drug2023-08-30Class II
AstrinGyn (Ferric Subsulfate) Aqueous, 259 mg/g, 8 gm Single Use Vials, Manufactured for CooperSurgical, Trumbull, CT 06611, NDC 59365-6065-0, Ref 6065.
Ecometics, Inc.
Hazard
CGMP Deviations: Products not manufactured under current good manufacturing practices.
Sold states
Nationwide in the USA
Affected count
92,967 vials
Manufactured in
19 Concord St, N/A, Norwalk, CT, United States
Products
AstrinGyn (Ferric Subsulfate) Aqueous, 259 mg/g, 8 gm Single Use Vials, Manufactured for CooperSurgical, Trumbull, CT 06611, NDC 59365-6065-0, Ref 6065.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1101-2023Don't want to check this manually?
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