Product Safety Recalls

Product Recall Tracker

CYCLOSPORINE Recall D-0770-2022

Description: Cequa (cyclosporine ophthalmic solution) 0.09%, packaged in 6 pouches x 10 single-use vials (0.25 mL each) per box, Manufactured for Sun Pharma Global FZE by: Laboratoire Unither, ZI de la Guerie, F-50211 Coutances Cedex, France, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 47335-506-96

CYCLOSPORINE Recall D-0770-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0770-2022
Event ID89917
BrandCEQUA
Generic NameCYCLOSPORINE
ManufacturerCYCLOSPORINE
Original Package?1
Active SubstanceCYCLOSPORINE
Drug RouteOPHTHALMIC
DistributionNationwide in the USA.
Quantity73,030 boxes
Recall ReasonSubpotent Drug and Presence of Particulate Matter: low out-of-specification results obtained for assay and the presence of particulate matter.
Drug ClassificationClass III
Drug Code Info20220413
Product NDC47335-506 47335-507
Product NUIN0000175457 N0000175458 N0000182141
Pharma Class (EPC)Calcineurin Inhibitor Immunosuppressant [EPC]
Recall Initiation Date20220401
Report Date20220413
Classification Date20220414
Address2 Independence Way
Princeton, NJ 08540-6620
United States
Recalling FirmSUN PHARMACEUTICAL INDUSTRIES INC
Initial Notification Letter
Unique Ingredient Identifier83HN0GTJ6D
Drug Application NumberNDA210913
Structured Product Labeling (SPL ID)be559875-7ddd-4045-b05f-f706d037cd1a
Structured Product Labeling (SPL Set ID)48c3d8a3-4289-4b52-9189-58b48596095c
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