Why it was recalled
CGMP Deviations: N-Nitroso Desloratadine impurity result exceeded the acceptable intake limit.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot # G201822, exp. date Jan 2024, 100 count G201823, exp. date Jan 2024, 100 count G201824, exp. date Jan 2024, 500 count
Where it was sold
Product was distributed nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0221-2024
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 20, 2023
- FDA report date
- Jan 17, 2024
- Quantity
- 100=29,184 bottles; 500=2922 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lupin Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-0221-2024, exactly as published.
Show all FDA fields
- City
- Baltimore
- State
- MD
- Status
- Terminated
- Country
- United States
- Event ID
- 93669
- Address
- Harborplace Tower
- Address (line 2)
- 111 S Calvert St Fl 21st
- Code information
- Lot # G201822, exp. date Jan 2024, 100 count G201823, exp. date Jan 2024, 100 count G201824, exp. date Jan 2024, 500 count
- Postal code
- 21202-6174
- Report date
- Jan 17, 2024
- Product type
- Drugs
- Recall number
- D-0221-2024
- Classification
- Class II
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Product quantity
- 100=29,184 bottles; 500=2922 bottles
- Termination date
- Apr 4, 2025
- Reason for recall
- CGMP Deviations: N-Nitroso Desloratadine impurity result exceeded the acceptable intake limit.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Product was distributed nationwide.
- Recall initiation date
- Dec 20, 2023
- Initial firm notification
- Letter
- Center classification date
- Jan 9, 2024