FDA recall D-1101-2023

Ecometics, Inc. · Class II · drug

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.

Distribution

Nationwide in the USA

Key facts

Status: Completed
Initiation date: 2023-08-09
Report date: 2023-08-30
Voluntary/Mandated: Voluntary: Firm initiated
Location: Norwalk, CT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1101-2023