Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Teligent Pharma, Inc. | Buena, New Jersey, United States | Makes it | Serious problems, FDA actionAug 31, 2021 · 8 inspections, 1 with FDA action |
Recalls
- Mar 15, 2022 · Class II · Teligent Pharma, Inc.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Lots: Batch: a) 16878, 16912, Exp. 5/31/2023; b)16878, Exp. 5/21/2023
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Gentamicin: every company that makes it
- Form
- ointment
- Strength
- 1 mg per 1 g
- Approval
- ANDA ANDA209233
- On the market since
- Dec 31, 2018
- Package NDCs
52565-090-1552565-090-30- Official label
- DailyMed (National Library of Medicine), updated Apr 2, 2018
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