Recall: D-0221-2024

Class II - Potentially Harmful

Class IIClassification

2023-12-20Initiated

TerminatedStatus

Lupin Pharmaceuticals Inc.Firm

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

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

Distribution

Product was distributed nationwide.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.