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DIFLUPREDNATE Recall D-1328-2022

Description: Difluprednate Ophthalmic Emulsion 0.05%, For Ophthalmic Use Only, Sterile, 5 mL bottles, Manufactured by Cipla Ltd., India, Manufactured for: Cipla USA, Inc., NJ 07059, NDC 69097-341-35.

DIFLUPREDNATE Recall D-1328-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1328-2022
Event ID90702
BrandDIFLUPREDNATE
Generic NameDIFLUPREDNATE
ManufacturerDIFLUPREDNATE
Original Package?1
Active SubstanceDIFLUPREDNATE
Drug RouteOPHTHALMIC
DistributionNationwide in the USA
Quantity7,992 bottles
Recall ReasonLack of Assurance of Sterility: Complaints received of defective container closure.
Drug ClassificationClass II
Drug Code Info20220817
Product NDC69097-341
Recall Initiation Date20220802
Report Date20220817
Classification Date20220805
Address10 Independence Blvd
Warren, NJ 07059-2730
United States
Recalling FirmCIPLA
Initial Notification Letter
Unique Ingredient IdentifierS8A06QG2QE
Drug Application NumberANDA211776
Structured Product Labeling (SPL ID)825a55a7-ffdf-4fde-bbb2-486cbd16e602
Structured Product Labeling (SPL Set ID)8a7254de-a7a2-476d-9295-c41926267ec9
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