Losartan Potassium Tablets Recalled for Excessive Azido Impurity
Macleods Pharma is recalling Losartan Potassium Tablets due to CGMP deviations with azido impurity levels exceeding acceptable limits. The recall affects 5.6 million tablets 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: FDA Class II recall with a manufacturing defect (CGMP deviation) resulting in excessive impurity levels. No illnesses or injuries have been reported; the hazard is theoretical risk from impurity exceeding acceptable limits, placing this at score 3 per the rubric for risk-of-harm products without reported injury.
Plain-English summary
Macleods Pharma Usa Inc is recalling Losartan Potassium Tablets, USP, 100 mg, due to current Good Manufacturing Practice (CGMP) deviations. Testing revealed that azido impurity levels in affected batches exceeded acceptable limits.
The recall affects approximately 5.6 million tablets distributed nationwide in three package sizes: 30-count, 90-count, and 1000-count bottles. Affected lot numbers are BLI2107B (expiration 06/2023), BLI2101A (expiration 12/2022), BLI2103A (expiration 12/2022), and BLI2105A (expiration 05/2023).
Consumers currently taking this product should consult their healthcare provider or pharmacist before discontinuing the medication. Healthcare providers and pharmacists should quarantine and return affected product to the manufacturer.
The recalled product
- Product
- LOSARTAN POTASSIUM (LOSARTAN POTASSIUM)
- Brand
- LOSARTAN POTASSIUM
- Manufacturer
- Macleods Pharma Usa Inc
- Category
- Drug
- 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.
Lot numbers (5)
- Lot # BLI2107B
- exp. date 06/2023 BLI2101A
- exp. date 12/2022 BLI2103A
- exp. date 12/2022 BLI2105A
- exp. date 05/2023
Distribution
Distributed nationwide across the United States.
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