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.

Recall Number: D-0221-2024

Firm: Lupin Pharmaceuticals Inc.

Classification: Class II

Status: Terminated

Report Date: 20240117

Initiation Date: 20231220

Termination Date: 20250404

CGMP Deviations: N-Nitroso Desloratadine impurity result exceeded the acceptable intake limit.

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.