Losartan Potassium 50 mg tablets recalled due to azido impurity
RemedyRepack Inc. is recalling Losartan Potassium 50 mg tablets due to CGMP deviations with azido impurity levels above acceptable limits. The affected lots were distributed to customers in Alaska and Pennsylvania.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 recall due to azido impurity levels exceeding acceptable limits. Although no illnesses or injuries have been reported, azido compounds represent a potential toxicological hazard, making this a risk-of-harm product.
Plain-English summary
RemedyRepack Inc. is recalling Losartan Potassium 50 mg tablets due to Good Manufacturing Practice (CGMP) deviations. The FDA identified azido impurity levels in the affected lots that exceed acceptable limits.
The affected product includes Losartan Potassium 50 mg tablets manufactured by Lupin Pharma in two package sizes: 30-count blister cards (NDC# 70518-3282-1) and 60-count blister cards (NDC# 70518-3282-0). The affected lots are B1467803-120621 (expiring June 30, 2022) and J0585793-121721 (expiring December 31, 2022). The product was distributed to customers in Alaska and Pennsylvania.
Patients currently taking this medication should contact their healthcare provider or pharmacist to determine if they received an affected lot. Do not stop taking your medication without medical advice. Return any affected product to your pharmacy.
The recalled product
- Product
- LOSARTAN POTASSIUM (LOSARTAN POTASSIUM)
- Brand
- LOSARTAN POTASSIUM
- Manufacturer
- RemedyRepack Inc.
- Category
- Drug
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 (3)
- Lot # B1467803-120621
- exp. date 06/30/2022 Lot # J0585793-121721
- exp. date 12/31/2022
Distribution
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