NDC 0065-0741
Tetracaine Hydrochloride 5 mg per 1 mL solution
On the label: Alcon Laboratories, Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Alcon Research LLC | Fort Worth, TX, United States | Makes it | No problems foundSep 15, 2022 · 12 inspections |
| Siegfried Evionnaz SA | Evionnaz, Switzerland | Makes the active ingredient | Problems found, fixed voluntarilyMar 31, 2023 · 6 inspections |
Recalls
- Apr 13, 2022 · Class II · Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
Lots: McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Tetracaine: every company that makes it
- Form
- solution, ophthalmic
- Strength
- 5 mg per 1 mL
- Approval
- NDA NDA208135
- On the market since
- Nov 2, 2016
- Package NDCs
0065-0741-120065-0741-14- Official label
- DailyMed (National Library of Medicine), updated Jan 19, 2024
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