FDA Recalls Desloratadine Tablets Due to Manufacturing Defect
Lupin Pharmaceuticals is recalling Desloratadine 5mg tablets distributed nationwide because N-Nitroso impurity levels exceeded acceptable limits. Affected lots expire in January 2024.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II classification with a manufacturing defect involving chemical impurities exceeding acceptable intake limits. Per the severity rubric, risk-of-harm products without reported injuries receive a High (3) score.
Plain-English summary
Lupin Pharmaceuticals is recalling specific lots of Desloratadine 5mg tablets because manufacturing testing found that N-Nitroso Desloratadine impurity levels exceeded acceptable intake limits. The affected product consists of 100-count and 500-count bottles that were distributed nationwide.
The affected lots are G201822, G201823, and G201824, which expire in January 2024. Consumers with this medication should not use it and should contact their pharmacy or healthcare provider about obtaining a replacement.
The recalled product
- Product
- DESLORATADINE (DESLORATADINE)
- Brand
- DESLORATADINE
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Category
- Drug — Antihistamine
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Lot # G201822
- exp. date Jan 2024
- 100 count G201823
- 100 count G201824
- 500 count
UPCs (1)
- 0368180153023
Distribution
Distributed nationwide across the United States.
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