Losartan Potassium Tablets Recalled Due to Trace Nitrosamine Impurity
Legacy Pharmaceutical Packaging LLC is recalling Losartan Potassium Tablets 50 mg due to trace amounts of the impurity NMBA found in the active ingredient.
What this means for you
Illness, injury, or structural failure has been reported. 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 presence of a nitrosamine impurity (NMBA) in a pharmaceutical product represents a significant health risk, aligning with the 'Severe' criteria for significant injury/property-damage reports or high-risk contamination.
Plain-English summary
Legacy Pharmaceutical Packaging LLC is recalling Losartan Potassium Tablets, USP, 50 mg, 30 tablet bottles. The recall involves 60,012 bottles of the prescription medication, which is distributed by The Kroger Co. and manufactured for Torrent Pharma Inc.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, trace amounts of N-Methylnitrosobutyric acid (NMBA) impurity were detected in the Active Pharmaceutical Ingredient (API). The affected product is identified by Lot 181598 with an expiration date of 02/2021.
The affected units were distributed in Tennessee and Arizona. Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance on obtaining a replacement medication.
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 6
- Manufacturer
- Legacy Pharmaceutical Packaging LLC
- Category
- Drug — Prescription Medication
- Affected units
- 60,012
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)
- Lot 181598
- 02/2021
Distribution
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