Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| LEO Laboratories Ltd. | Dublin, Ireland | Makes it, tests it, packages it and labels it | Problems found, fixed voluntarilyJan 30, 2026 · 6 inspections |
Recalls
- Jan 19, 2017 · Class II · Leo Pharma Inc
Incorrect/Undeclared excipients: inadvertent omission of a drug excipient from the the Authorized Generic label and also a warning regarding contact dermatitis from the brand product labeling not being incorporated into the Authorized Generic labeling.
Lots: Lot #: a) EK8760, Exp 2/17; EL1115, Exp 3/17; EL2358, Exp 4/17; EL6143, Exp 7/17; EM0837, Exp 10/17; EM2088, 12/17; A20899, Exp 5/18; A24492, Exp 6/18; b) EK8764, Exp 2/17; EL6145, Exp 7/17; EM2091, Exp 2/17; A25206, Exp 6/18.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Calcipotriene: every company that makes it
- Form
- cream, topical
- Strength
- 50 ug per 1 g
- Approval
- NDA AUTHORIZED GENERIC NDA020554
- On the market since
- Oct 1, 1996
- Package NDCs
66993-877-6166993-877-78- Official label
- DailyMed (National Library of Medicine), updated Dec 12, 2022
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