Losartan Potassium and Hydrochlorothiazide tablets recalled for AZIDO impurity
Lupin Pharmaceuticals is recalling Losartan Potassium and Hydrochlorothiazide tablets distributed nationwide due to elevated AZIDO impurity levels detected during manufacturing quality control.
What this means for you
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 recall with no reported illnesses or injuries. The presence of a chemical impurity above acceptable limits in a pharmaceutical product represents a risk-of-harm situation where adverse events have not yet been reported, meeting the rubric criterion for Score 3.
Plain-English summary
Lupin Pharmaceuticals Inc. is recalling multiple lot numbers of Losartan Potassium and Hydrochlorothiazide Tablets USP, 50 mg/12.5 mg, a combination blood pressure medication. The recall affects both 30-count and 90-count bottles that were distributed nationwide. A total of 1,214,016 bottles are involved, with lot numbers dated from 2022 through 2023.
The recall was initiated after current good manufacturing practice (CGMP) deviations revealed elevated levels of AZIDO impurity in affected batches. The impurity levels exceeded acceptable limits. No illnesses or injuries have been reported in connection with these products.
Consumers and healthcare providers who possess this medication should check their lot numbers against the list of recalled batches. If the lot number matches, the medication should be discontinued immediately. Patients should contact their healthcare provider or pharmacist for guidance on obtaining a safe replacement.
The recalled product
- Product
- LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE)
- Brand
- LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Category
- Drug — Blood Pressure Medication
- Hazard
- azido-impurity
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
UPCs (2)
- 0368180215066
- 0368180217060
Distribution
Distributed nationwide across the United States.
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