Reported Jan 17, 2024 · Terminated
Desloratadine Tablets USP 5mg a) 100 count (NDC 68180-153-01) and b) 500 count (NDC 68180-153-02) bottles, Rx Only,…
Lupin Pharmaceuticals Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Lupin Pharmaceuticals Inc. · Harborplace Tower · Baltimore, MD · 21202-6174
Is this the product you have?
- Desloratadine Tablets USP 5mg a) 100 count (NDC 68180-153-01) and b) 500 count (NDC 68180-153-02) bottles, Rx Only
- Manufactured forLupin Pharmaceuticals, Inc. Baltimore, Maryland 21202
- Lot codes and dates
Lot # G201822exp. date Jan 2024100 count G201823exp. date Jan 2024100 count G201824exp. date Jan 2024500 count
- Amount recalled
- 100=29,184 bottles; 500=2922 bottles
Where it was sold
- Nationwide
Why it was recalled
CGMP Deviations: N-Nitroso Desloratadine impurity result exceeded the acceptable intake limit.
This product could cause temporary or reversible health problems — stop using it.
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