FDA Drug recall D-0488-2024
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…
- FDA Drug
- Class II
- terminated
- Published 2024-05-15
On 2024-05-15 the FDA classified a Class II recall of 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… by Fdc, citing defective Container: yellow-colored spike from cap lodged in the nozzle. Firm received several complaints from customers.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0488-2024 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2024-04-25 |
| Published | 2024-05-15 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Fdc |
| Distribution | NJ |
Product
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
Reason
Defective Container: yellow-colored spike from cap lodged in the nozzle. Firm received several complaints from customers.
Identifiers
| ndc | 64980-513-05 |
|---|---|
| ndc | 64980-513-01 |
| ndc | 64980-513-15 |
| ndc | 64980-514-05 |
| ndc | 64980-514-01 |
| ndc | 64980-514-15 |
| code_info | Lot #: a) 083H008, Exp. Date 07/2025; 083G003, Exp. Date 06/2025; 083J017, Exp. Date 09/2025; b) 083I013, Exp. Date 08/2025. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0488-2024%22
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