Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| LEO Laboratories Ltd. | Dublin, Ireland | Makes it | Problems found, fixed voluntarilyJan 30, 2026 · 6 inspections |
Recalls
- Jan 16, 2017 · Class III · Leo Pharma Inc
Labeling: Incorrect or missing package insert: the affected product was packaged with an out-of-date package insert (PI) dated February 2014.
Lots: Lot #: (a): EK9025, Exp. 2/28/2017; EL1057, Exp. 3/31/2017; EL4637, Exp. 6/30/2017; EM0825B, Exp. 11/30/2017; EM3992, Exp. 1/31/2019; A22902, Exp. 5/31/2019; A31838, Exp. 9/30/2019 Lot #:EK7007A, EK7007AA, Exp. 1/31/2017; EL2024, EL2979, Exp. 5/31/2017; EL8069, Exp. 10/31/2017; EA20780AA, Exp…
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 and Calcipotriene: every company that makes it
- Form
- suspension, topical
- Strength
- 50 ug per 1 g / 0.5 mg per 1 g
- Approval
- NDA NDA022185
- On the market since
- Jun 1, 2008
- Package NDCs
50222-501-0650222-501-5150222-501-66- Official label
- DailyMed (National Library of Medicine), updated Nov 30, 2017
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