Desloratadine Tablets USP 5mg a) 100 count recall: Impurity Out of Spec
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…
Why was Desloratadine Tablets USP 5mg a) 100 count recalled?
CGMP Deviations: N-Nitroso Desloratadine impurity result exceeded the acceptable intake limit.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot # G201822, exp. date Jan 2024, 100 count G201823, exp. date Jan 2024, 100 count G201824, exp. date Jan 2024, 500 count
- 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…
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Quantity
- 100=29,184 bottles; 500=2922 bottles
- Distribution
- Product was distributed nationwide.
- Recall date
- January 17, 2024
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)