TIMOLOL MALEATE Recall D-0488-2024
Description: Timolol Maleate Ophthalmic Solution, USP, 0.5%, packaged in a) 5mL bottles (NDC 64980-514-05), and b) 15 mL bottles (NDC 64980-514-15), Rx only, Manufactured by: FDC Limited, Maharashtra, India, Distributed by: Rising Pharmaceuticals, Inc, NJ
TIMOLOL MALEATE Recall D-0488-2024 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0488-2024 |
| Event ID | 94466 |
| Brand | TIMOLOL MALEATE |
| Generic Name | TIMOLOL MALEATE |
| Manufacturer | TIMOLOL MALEATE |
| Original Package? | 1 |
| Active Substance | TIMOLOL MALEATE |
| Drug Route | OPHTHALMIC |
| Distribution | New Jersey Only |
| Quantity | 382,104 units |
| Recall Reason | Defective Container: yellow-colored spike from cap lodged in the nozzle. Firm received several complaints from customers. |
| Drug Classification | Class II |
| Drug Code Info | 20240515 |
| Product NDC | 64980-513 64980-514 |
| Drug UPC | 0364980513050 0364980514057 |
| Recall Initiation Date | 20240425 |
| Report Date | 20240515 |
| Classification Date | 20240507 |
| Address | B-8 MIDC Industrial AreaWaluj District Aurangabad, Maharashtra State, N/A N/A India |
| Recalling Firm | FDC Limited |
| Initial Notification | Letter |
| Unique Ingredient Identifier | P8Y54F701R |
| Drug Application Number | ANDA077259 |
| Structured Product Labeling (SPL ID) | 8eaa2d62-25cf-4b14-bd14-40bf2c2458e0 |
| Structured Product Labeling (SPL Set ID) | 2ed21930-1e05-46de-8acd-cb6f4798a7fa |
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