Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Ophtapharm AG | Hettlingen, Switzerland | Makes it, tests it, packages it and labels it | Problems found, fixed voluntarilyFeb 28, 2020 · 5 inspections |
Recalls
- Dec 20, 2018 · Class III · Akorn Inc
Failed Stability Specifications: out of specification results for opalescence at 7 month stability study.
Lots: Lots: 426007 and 426008, exp 4/2020
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Dorzolamide and Timolol: every company that makes it
- Form
- solution/ drops
- Strength
- 5 mg per 1 mL / 20 mg per 1 mL
- Approval
- NDA NDA020869
- On the market since
- Apr 30, 2014
- Package NDCs
17478-605-10- Official label
- DailyMed (National Library of Medicine), updated Dec 2, 2022
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