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DIFLUPREDNATE Recall D-1498-2022

Description: Difluprednate Ophthalmic Emulsion, 0.05%, 5 mL bottle, RX only, Manufactured for Exelan Pharmecuticals, Inc., Boca Raton, FL 33432, NDC 76282-708-50.

DIFLUPREDNATE Recall D-1498-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1498-2022
Event ID90796
BrandDIFLUPREDNATE
Generic NameDIFLUPREDNATE
ManufacturerDIFLUPREDNATE
Original Package?1
Active SubstanceDIFLUPREDNATE
Drug RouteOPHTHALMIC
DistributionNationwide in the USA
Quantity3,468 bottles
Recall ReasonLack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise sterility.
Drug ClassificationClass II
Drug Code Info20220914
Product NDC76282-708
Recall Initiation Date20220822
Report Date20220914
Classification Date20220907
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)8cddb271-2bf9-4493-b5cf-547f56c46caf
Structured Product Labeling (SPL Set ID)f7744cc9-bc5b-4642-8b36-07136704910a
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