Losartan Potassium and Hydrochlorothiazide tablets recalled for AZIDO impurity
Lupin Pharmaceuticals recalls Losartan Potassium and Hydrochlorothiazide tablets nationwide due to manufacturing deviations that resulted in AZIDO impurity levels above acceptable limits.
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 confirmed manufacturing deviation (CGMP violation) resulting in AZIDO chemical impurity exceeding acceptable limits. This represents a risk-of-harm pharmaceutical product where injury has not yet been reported, fitting the rubric criterion for score 3.
Plain-English summary
Lupin Pharmaceuticals Inc. is recalling specific lots of Losartan Potassium and Hydrochlorothiazide Tablets USP (100 mg/12.5 mg) distributed nationwide. The recall affects 2,361,924 bottles in both 30-count (NDC 68180-216-06) and 90-count (NDC 68180-216-09) configurations.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations in which AZIDO impurity levels were observed to be above acceptable limits. This manufacturing defect was identified at the Lupin Limited facility in Pithampur, India, which manufactures the product for Lupin Pharmaceuticals Inc. in Baltimore, Maryland.
Affected lot numbers for 30-count bottles include H001878, H002178, H002626, and H102149. Numerous 90-count bottle lots from H001600 through H102271 are also affected, with expiration dates ranging from May 2022 through September 2023.
Patients currently taking this medication should contact their healthcare provider before discontinuing use. Consumers should return any affected product to their pharmacy or the manufacturer.
The recalled product
- Product
- LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE)
- Brand
- LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Hazard
- azido-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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