NDC 52565-019
Betamethasone Dipropionate 0.5 mg per 1 g ointment
On the label: Teligent Pharma, Inc..
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
- Feb 2, 2021 · Class III · Teligent Pharma, Inc.
Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate.
Lots: Lot #: 14297, Exp 9/2021; 15372, Exp 3/2022; 15841, Exp 8/2022 - Feb 2, 2021 · Class III · Teligent Pharma, Inc.
Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate.
Lots: Lot #: 14297, Exp 9/2021; 15757, Exp 6/2022; 15840, Exp 7/2022; 15970, Exp 9/2022; 15993, Exp 9/2022 - May 20, 2019 · Class III · Teligent Pharma, Inc.
Failed Impurities/Degradation Specifications
Lots: Lot 11852, exp date 08/2020
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Betamethasone: every company that makes it
- Form
- ointment
- Strength
- 0.5 mg per 1 g
- Approval
- ANDA ANDA206118
- On the market since
- Oct 30, 2017
- Package NDCs
52565-019-1552565-019-51- Official label
- DailyMed (National Library of Medicine), updated Jul 17, 2018
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