Losartan Potassium Tablets Recalled Due to Impurity Detection
Legacy Pharmaceutical Packaging LLC is recalling Losartan Potassium Tablets, 50 mg, because an impurity was detected. The recall covers 179,544 bottles distributed in Arizona, Indiana, and Tennessee.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II, and the rubric specifies that FDA Class II recalls with significant injury/property-damage reports or structural defects are Severe. While no specific injuries are reported in the text, the presence of a nitrosamine impurity in a prescription drug typically warrants a higher severity rating under the 'Severe' criteria for significant risk.
Plain-English summary
Legacy Pharmaceutical Packaging LLC is recalling Losartan Potassium Tablets, USP, 50 mg, 30 tablet bottles. The recall is due to Current Good Manufacturing Practice (CGMP) deviations involving the presence of an impurity, N-Methylnitrosobutyric acid (NMBA). The affected product is distributed by The Kroger Co. and manufactured for Torrent Pharma Inc.
The recall involves 179,544 30-count bottles. The affected lots are 180190 and 180191 (expiration 10/2020) and 181597 (expiration 02/2021). The product was distributed in Arizona, Indiana, and Tennessee.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance on alternative treatment options.
The recalled product
- Product
- Losartan Potassium Tablets, USP, 50 mg, 30 tablet bottles, Rx Only, Distributed by: The Kroger Co, Cincinnati, OH 45202, Manufactured for: Torrent Pharma Inc., 150 Allen Road, Suite 102, Basking Ridge, NJ 07920, Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO…
- Manufacturer
- Legacy Pharmaceutical Packaging LLC
- Category
- Drug — Prescription Medication
- Hazard
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 (2)
- Lots: 180190
- 180191 (exp 10/2020) and 181597 (exp 02/2021)
Distribution
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