FDARecalled Jan 17, 2024 · #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.
Hazard
Class II — temporary health risk
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CGMP Deviations: N-Nitroso Desloratadine impurity result exceeded the acceptable intake limit. Classification: Class II Distribution: Product was distributed nationwide.
Product details
- Product
- 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.
- Type
- Drugs
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Model numbers
- G201822
- UPCs
- —