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OXYBUTYNIN CHLORIDE Recall D-0096-2024

Description: Oxybutynin Chloride Extended-Release Tablet USP, 5 mg, 100 count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Baddi, India. Distributed by: Zydus Pharmaceuticals (USA) Inc. NDC # 68382-255-01

OXYBUTYNIN CHLORIDE Recall D-0096-2024 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0096-2024
Event ID93260
BrandOXYBUTYNIN
Generic NameOXYBUTYNIN
ManufacturerOXYBUTYNIN
Original Package?1
Active SubstanceOXYBUTYNIN CHLORIDE
Drug RouteORAL
DistributionNationwide.
Recall ReasonFailed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
Drug ClassificationClass II
Drug Code Info20231115
Product NDC68382-255 68382-256 68382-257
Recall Initiation Date20231019
Report Date20231115
Classification Date20231108
Address73 Route 31 N
Pennington, NJ 08534-3601
United States
Recalling FirmZydus Pharmaceuticals (USA) Inc
Initial Notification Letter
Unique Ingredient IdentifierL9F3D9RENQ
Drug Application NumberANDA202332
Structured Product Labeling (SPL ID)f54e4d4e-91be-4e10-a446-57ed5e1843a1
Structured Product Labeling (SPL Set ID)c042bf06-79a3-4dc7-ae05-3ef3cfae9d44
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