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
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0096-2024 |
| Event ID | 93260 |
| Brand | OXYBUTYNIN |
| Generic Name | OXYBUTYNIN |
| Manufacturer | OXYBUTYNIN |
| Original Package? | 1 |
| Active Substance | OXYBUTYNIN CHLORIDE |
| Drug Route | ORAL |
| Distribution | Nationwide. |
| Recall Reason | Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point. |
| Drug Classification | Class II |
| Drug Code Info | 20231115 |
| Product NDC | 68382-255 68382-256 68382-257 |
| Recall Initiation Date | 20231019 |
| Report Date | 20231115 |
| Classification Date | 20231108 |
| Address | 73 Route 31 N Pennington, NJ 08534-3601 United States |
| Recalling Firm | Zydus Pharmaceuticals (USA) Inc |
| Initial Notification | Letter |
| Unique Ingredient Identifier | L9F3D9RENQ |
| Drug Application Number | ANDA202332 |
| 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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