Losartan Potassium and Hydrochlorothiazide Tablets Recalled for Impurity
Lupin Pharmaceuticals is recalling Losartan Potassium and Hydrochlorothiazide 100 mg/25 mg tablets nationwide due to AZIDO impurity levels above acceptable limits. Patients should consult their healthcare provider about their medication.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall for manufacturing deviation resulting in above-acceptable AZIDO impurity levels. No illnesses or injuries reported. Class II indicates a health hazard unlikely to cause serious adverse health consequences.
Plain-English summary
Lupin Pharmaceuticals Inc. is recalling Losartan Potassium and Hydrochlorothiazide tablets (100 mg/25 mg) distributed nationwide. The recall affects 303,696 bottles in 30-count and 90-count bottles (NDC# 68180-217-06 and 68180-217-09).
The recall was issued due to Current Good Manufacturing Practice (CGMP) deviations that resulted in AZIDO impurity levels exceeding acceptable limits. The affected lot numbers span from April 2022 through July 2023.
Patients currently taking this medication should not stop without consulting their healthcare provider or pharmacist. Those with affected lot numbers should contact their pharmacy or healthcare provider for guidance on their treatment.
The recalled product
- Product
- LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE)
- Brand
- LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Category
- Drug — Antihypertensive
- Hazard
- impurity
- manufacturing-defect
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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