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) 16410, 16438, Exp. 1/31/2023; 16882, Exp. 4/30/2023; b) 15349, Exp. 2/28/2022; 16410, 16438, Exp. 1/31/2023; 16882, Exp. 4/30/2023; c) 16410, 16438, Exp. 1/31/2023 - Jul 19, 2021 · Class II · Teligent Pharma, Inc.
Correct Labeled Product Mispack
Lots: Lot # 16630; Exp 03/2023
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Econazole: every company that makes it
- Form
- cream
- Strength
- 10 mg per 1 g
- Approval
- ANDA ANDA076574
- On the market since
- Aug 1, 2013
- Package NDCs
52565-022-1552565-022-3052565-022-85- Official label
- DailyMed (National Library of Medicine), updated Jul 19, 2018
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