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.
Reason for recall: CGMP Deviations: N-Nitroso Desloratadine impurity result exceeded the acceptable intake limit.
Recall initiated: 20231220
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated