Losartan Potassium Tablets Recalled Due to AZIDO Impurity Above Limits
Macleods Pharma USA Inc. is recalling Losartan Potassium 25 mg tablets due to higher-than-acceptable levels of AZIDO impurity from manufacturing deviations. The affected lots were distributed nationwide.
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: This is an FDA Class II drug recall for AZIDO impurity exceeding acceptable limits. The regulatory Class II designation and manufacturing process deviation, without documented patient harm events, support a High severity rating per the rubric criterion for risk-of-harm products.
Plain-English summary
Macleods Pharma USA Inc. is recalling Losartan Potassium Tablets, USP, 25 mg due to Current Good Manufacturing Practice (CGMP) deviations. Testing identified that levels of AZIDO impurity in the affected lots exceed acceptable limits.
The recall affects Losartan Potassium Tablets in 90-count bottles (NDC # 33342-044-10) and 1000-count bottles (NDC # 33342-044-44). The affected lot numbers are BLH2002A, BLH2003B, and BLH2004A, all with expiration dates of November 2022. Approximately 2,786,720 tablets across both package sizes are affected.
These products were distributed nationwide. The FDA recall number is D-0832-2022.
The recalled product
- Product
- LOSARTAN POTASSIUM (LOSARTAN POTASSIUM)
- Brand
- LOSARTAN POTASSIUM
- Manufacturer
- Macleods Pharma Usa Inc
- Category
- Drug
- 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.
Lot numbers (4)
- Lot # BLH2002A
- exp. date 11/2022 BLH2003B
- exp. date 11/2022 BLH2004A
- exp. date 11/2022
Distribution
Distributed nationwide across the United States.
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- HighLosartan Potassium Tablets Recalled for Manufacturing Impurity Issues
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- ModerateLosartan Potassium tablets recalled for excessive AZIDO impurity
FDA (Drugs) · 2022-06-08
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