Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Glenmark Pharmaceuticals Limited | Dhar, India | Makes it and tests it | Serious problems, FDA actionFeb 14, 2025 · 8 inspections, 1 with FDA action |
Recalls
- Jul 11, 2022 · Class III · Glenmark Pharmaceuticals Inc., USA
Defective Container: Tube split from side seam
Lots: Lot #s: a) 15200058, 15200066, 15200067, Exp 06/2022; 15200075, Exp 07/2022; 15200094, Exp 08/2022; 15200119, 15200120, 15200122, Exp 09/2022; 15200131, 15200132, Exp 10/2022; 15200133, 15200134, 15200136, 15200139, Exp 11/2022; 15210033, 15210035, 15210036, 15210038 Exp 01/2023; 15210092, 152100…
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Tacrolimus: every company that makes it
- Form
- ointment, topical
- Strength
- 1 mg per 1 g
- Approval
- ANDA ANDA210393
- On the market since
- Apr 16, 2018
- Package NDCs
68462-534-3568462-534-6568462-534-94- Official label
- DailyMed (National Library of Medicine), updated Apr 15, 2026
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