FDA recall D-0221-2024

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.

Distribution

Product was distributed nationwide.

Key facts

Status

Terminated

Initiation date

2023-12-20

Report date

2024-01-17

Termination date

2025-04-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Baltimore, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0221-2024