Lupin Pharmaceuticals recalls 5mg desloratadine tablets (NDC 68180-153-01/02) due to N-Nitroso desloratadine impurity exceeding safe limits. Rx-only products with specific lot numbers and expiration dates.
CGMP Deviations: N-Nitroso Desloratadine impurity result exceeded the acceptable intake limit.
Lupin Pharmaceuticals is recalling 5mg desloratadine tablets that may contain an impurity exceeding safe limits. This could pose a health risk with long-term use, though the risk is not immediately dangerous.
The tablets contain an impurity called N-Nitroso desloratadine that exceeds the acceptable intake limit. This impurity could potentially cause health issues with long-term use, but the risk is not immediate or severe.
Prescription owners of Lupin's 5mg desloratadine tablets (NDC 68180-153-01 or 02) with specific lot numbers and expiration dates. People taking this medication for allergies are most at risk.
Check for the product name 'Desloratadine Tablets USP 5mg' with NDC codes 68180-153-01 (100 count) or 68180-153-02 (500 count). The lot numbers are G201822, G201823, or G201824, all expiring in January 2024.
Verify the NDC code and lot number on the bottle to confirm if it's part of the recall.
Ask your pharmacist if you have the recalled tablets and how to safely dispose of them.
This recall is for prescription-only products (Rx Only).
The tablets contain N-Nitroso desloratadine impurity exceeding the acceptable intake limit.
Check for NDC codes 68180-153-01 (100 count) or 68180-153-02 (500 count) with lot numbers G201822, G201823, or G201824, expiring in January 2024.
We’ve drafted a message you can send Lupin Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0221-2024 — Lupin Pharmaceuticals Lupin Pharmaceuticals Hello, I own a Lupin Pharmaceuticals that is covered by recall D-0221-2024 from Lupin Pharmaceuticals. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
