Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Lupin Limited | Salcette, India | Makes it and packages it | Problems found, fixed voluntarilyNov 21, 2025 · 9 inspections, 1 with FDA action |
Recalls
- Dec 20, 2023 · Class II · Lupin Pharmaceuticals Inc.
CGMP Deviations: N-Nitroso Desloratadine impurity result exceeded the acceptable intake limit.
Lots: Lot # G201822, exp. date Jan 2024, 100 count G201823, exp. date Jan 2024, 100 count G201824, exp. date Jan 2024, 500 count
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Desloratadine: every company that makes it
- Form
- tablet, film coated, oral
- Strength
- 5 mg
- Approval
- ANDA ANDA078352
- On the market since
- Feb 25, 2013
- Package NDCs
68180-153-0168180-153-0268180-153-0368180-153-0668180-153-1168180-153-12- Official label
- DailyMed (National Library of Medicine), updated Jun 30, 2026
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