December 2023 FDA Recall Desloratadine by Lupin Pharmaceuticals Inc.
D-0221-2024 - CGMP Deviations

This Class II drug recall was voluntarily initiated by Lupin Pharmaceuticals Inc. on December 20, 2023 for the product Desloratadine. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0221-2024

Reason for Recall
CGMP Deviations: N-Nitroso Desloratadine impurity result exceeded the acceptable intake limit.
Initiated
12-20-2023
Reported
01-17-2024
Quantity
100=29,184 bottles; 500=2922 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
93669
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Lupin Pharmaceuticals Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-04-2025
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# G201822, exp. date Jan 2024, 100 count G201823, exp. date Jan 2024, 100 count G201824, exp. date Jan 2024, 500 count

Affected Packages Involved in this Recall

68180-153-01 Desloratadine
68180-153-03 Desloratadine
68180-153-06 Desloratadine
68180-153-02 Desloratadine
68180-153-11 Desloratadine
68180-153-12 Desloratadine