Product Safety Recalls

Product Recall Tracker

Recall D-1101-2023

Description: AstrinGyn (Ferric Subsulfate) Aqueous, 259 mg/g, 8 gm Single Use Vials, Manufactured for CooperSurgical, Trumbull, CT 06611, NDC 59365-6065-0, Ref 6065.

Recall D-1101-2023 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1101-2023
Event ID92857
DistributionNationwide in the USA
Quantity92,967 vials
Recall ReasonCGMP Deviations: Products not manufactured under current good manufacturing practices.
Drug ClassificationClass II
Drug Code Info20230830
Recall Initiation Date20230809
Report Date20230830
Classification Date20230824
Address19 Concord St
Norwalk, CT 06854-3706
United States
Recalling FirmEcometics, Inc.
Initial Notification Letter
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