Product Safety Recalls

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DIFLUPREDNATE Recall D-1283-2022

Description: Difluprednate Ophthalmic Emulsion, 0.05%, 5ml bottles, Rx only, Mfd. by: Cipla Ltd., India At M/S Indoco Remedies Limited., L-32, 33, 34, Verna Industrial area, Verna - Goa, 403722, India; Mfd. for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-341-35.

DIFLUPREDNATE Recall D-1283-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1283-2022
Event ID90608
BrandDIFLUPREDNATE
Generic NameDIFLUPREDNATE
ManufacturerDIFLUPREDNATE
Original Package?1
Active SubstanceDIFLUPREDNATE
Drug RouteOPHTHALMIC
DistributionNationwide in the USA
Quantity8,136 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 Info20220727
Product NDC69097-341
Recall Initiation Date20220714
Report Date20220727
Classification Date20220720
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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