Recalls / Class II
Class IID-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.
- Brand name
- Desloratadine
- Generic name
- Desloratadine
- Active ingredient
- Desloratadine
- Route
- Oral
- NDC
- 68180-153
- FDA application
- ANDA078352
- Affected lot / code info
- Lot # G201822, exp. date Jan 2024, 100 count G201823, exp. date Jan 2024, 100 count G201824, exp. date Jan 2024, 500 count
Why it was recalled
CGMP Deviations: N-Nitroso Desloratadine impurity result exceeded the acceptable intake limit.
Recalling firm
- Firm
- Lupin Pharmaceuticals Inc.
- Manufacturer
- Lupin Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- Harborplace Tower, 111 S Calvert St Fl 21st, Baltimore, Maryland 21202-6174
Distribution
- Quantity
- 100=29,184 bottles; 500=2922 bottles
- Distribution pattern
- Product was distributed nationwide.
Timeline
- Recall initiated
- 2023-12-20
- FDA classified
- 2024-01-09
- Posted by FDA
- 2024-01-17
- Terminated
- 2025-04-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0221-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.