FDA Drug recall D-1368-2020
Timolol Maleate Sterile Opthalmic Solution,USP 0.25%, 5 mL, Rx Only, For Topical Application, Distributed by: Rising Pharmaceuticals, Inc
- FDA Drug
- Class III
- terminated
- Published 2020-07-01
On 2020-07-01 the FDA classified a Class III recall of Timolol Maleate Sterile Opthalmic Solution,USP 0.25%, 5 mL, Rx Only, For Topical Application, Distributed by: Rising Pharmaceuticals, Inc by Rising Pharmaceuticals, citing labeling: Label mix-up: A case of Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml, had the outer carton for Timolol Maleate Sterile Ophthalmic solution USP 0.5%, 5ml bu….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1368-2020 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2019-11-15 |
| Published | 2020-07-01 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Rising Pharmaceuticals |
| Distribution | US |
Product
Timolol Maleate Sterile Opthalmic Solution,USP 0.25%, 5 mL, Rx Only, For Topical Application, Distributed by: Rising Pharmaceuticals, Inc. Saddle Brook, NJ 07863, Manufactured by: FDC Limited B-8, MDC Industrial Area, Waluj, Aurangabad - 431-136 Maharashtra, India, NDC 64980-513-05
Reason
Labeling: Label mix-up: A case of Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml, had the outer carton for Timolol Maleate Sterile Ophthalmic solution USP 0.5%, 5ml but the bottle inside was Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml.
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 # 089A016, Exp 12/2020 |
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-1368-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.