Product Safety Recalls

Product Recall Tracker

Recall D-1102-2023

Description: Lugol's (Strong Iodine Solution USP), Each mL contains Iodine 0.05gm and potassium iodide 0.100gm, 8mL Single Use Vials, Rx Only, Manufactured for CooperSurgical, Trumbull, CT 06611, NDC 59365-6064-0, Ref 6064.

Recall D-1102-2023 Information

Mandated?Voluntary: Firm initiated
Recall NumberD-1102-2023
Event ID92857
DistributionNationwide in the USA
Quantity38,486 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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