FDAFDA · Food and drugs·Recall number D-0221-2024
Desloratadine Tablets USP 5mg a) 100 count (NDC 68180-153-01) and b) 500 count (NDC 68180-153-02) bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202.
Published January 17, 2024 · Recall initiated: December 20, 2023
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: N-Nitroso Desloratadine impurity result exceeded the acceptable intake limit.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- DESLORATADINE
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Distributor
- Product was distributed nationwide.
- UPC
- 0368180153023
- Lot
- Lot # G201822, exp. date Jan 2024, 100 count G201823, exp. date Jan 2024, 100 count G201824, exp. date Jan 2024, 500 count
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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