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 |
Similar To |