Product Safety Recalls

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POVIDONE-IODINE Recall D-1008-2022

Description: Betadine 5%, Sterile Ophthalmic Prep Solution, (povidine-iodine ophthalmic solution), 1 fl. oz. (30 mL), Rx only, Mfd for: Alcon Surgical Inc., NDC 0065-0411-30

POVIDONE-IODINE Recall D-1008-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1008-2022
Event ID89646
BrandBETADINE
Generic NamePOVIDONE-IODINE
ManufacturerPOVIDONE-IODINE
Original Package?1
Active SubstancePOVIDONE-IODINE
Drug RouteOPHTHALMIC
DistributionUSA nationwide.
Quantity799 cartons/1 bottle each
Recall ReasoncGMP deviations: Temperature abuse
Drug ClassificationClass II
Drug Code Info20220615
Product NDC0065-0411
Product NUIN0000175486 M0011640
Drug UPC0035410000074
Pharma Class (EPC)Antiseptic [EPC]
Pharma Class (CS)Iodine [CS]
Recall Initiation Date20220413
Report Date20220615
Classification Date20220609
Address9954 Maryland DriveDeep Run Iii Ste. 4000
Richmond, VA 23233
United States
Recalling FirmMckesson Medical-Surgical Inc. Corporate Office
Initial Notification Letter
Unique Ingredient Identifier85H0HZU99M
Drug Application NumberNDA018634
Structured Product Labeling (SPL ID)0fcbe927-f60a-4e9b-b83f-07b9b9ae871d
Structured Product Labeling (SPL Set ID)b026de1b-9949-4557-ac49-c7b0038c24cd
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