NDC 45865-121
Timolol Maleate 5 mg per 1 mL solution/ drops
On the label: Medsource Pharmaceuticals. It's repackaged: Medsource Pharmaceuticals rebottles it from Rising Pharma Holdings, Inc.'s NDC 64980-514.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| FDC Limited | Chhatrapati Sambhajinagar, India | Makes it and tests it | No problems foundFeb 12, 2023 · 5 inspections |
Repackaging site
- Medsource Pharmaceuticals, Rancho Santa Margarita, CA, United States · relabels it
Recalls
- Jul 5, 2025 · Class II · FDC Limited
Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle.
Lots: Lot#: 083L061, Exp.: 11/2025. - Apr 18, 2025 · Class II · FDC Limited
Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
Lots: Lot #: 083I098, Exp. Date 08/31/2025 - Jan 23, 2025 · Class II · FDC Limited
Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
Lots: Lot#: 083J033, Exp. Date 09/2025 - Dec 5, 2024 · Class II · FDC Limited
Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
Lots: Lot #: 083I006, Exp 08/31/2025 - Oct 29, 2024 · Class II · FDC Limited
Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
Lots: Lot #: 083L051, Exp. Date: 11/2025 - Aug 12, 2024 · Class II · FDC Limited
Defective Container: patients are unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
Lots: Lot #: a) 083K063, Exp 10/31/2025; b) 083I091, Exp 08/31/2025. - Jul 18, 2024 · Class II · FDC Limited
Defective container; yellow colored spike from cap lodged in the nozzle
Lots: Lot Number: 083J022, Expiration Date: September- 25; 083L046, Expiration date: November- 25; 083H009, Expiration date: July- 25 - Apr 25, 2024 · Class II · FDC Limited
Defective Container: yellow-colored spike from cap lodged in the nozzle. Firm received several complaints from customers.
Lots: Lot #: a) 083H008, Exp. Date 07/2025; 083G003, Exp. Date 06/2025; 083J017, Exp. Date 09/2025; b) 083I013, Exp. Date 08/2025. - Nov 15, 2019 · Class III · Rising Pharmaceuticals, Inc.
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.
Lots: Lot # 089A016, Exp 12/31/2020 - Nov 15, 2019 · Class III · Rising Pharmaceuticals, Inc.
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.
Lots: Lot # 089A016, Exp 12/2020
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Timolol: every company that makes it
- Form
- solution/ drops
- Strength
- 5 mg per 1 mL
- Approval
- ANDA ANDA077259
- On the market since
- Jul 1, 2020
- Package NDCs
45865-121-01- Official label
- DailyMed (National Library of Medicine), updated Nov 14, 2020
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