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
- Apr 9, 2021 · Class II · Teligent Pharma, Inc.
Failed Impurities/Degradation Specifications:
Lots: Lot #13974 EXP 7/2021
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Flurandrenolide: every company that makes it
- Form
- ointment
- Strength
- 0.5 mg per 1 g
- Approval
- ANDA ANDA207851
- On the market since
- Dec 30, 2016
- Package NDCs
52565-017-1552565-017-3052565-017-60- Official label
- DailyMed (National Library of Medicine), updated Dec 30, 2016
Got it by mail or from a pharmacy you don't know? Look the pharmacy up on Who Filled My Rx?