Losartan Potassium Tablets Recalled Due to Impurity Detection
Legacy Pharmaceutical Packaging LLC is recalling Losartan Potassium Tablets, 25 mg, because an impurity was detected. The recall involves 456,732 bottles distributed by Wal-Mart.
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. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when involving significant chemical impurities like NMBA which are potential carcinogens.
Plain-English summary
Legacy Pharmaceutical Packaging LLC is recalling Losartan Potassium Tablets, USP, 25 mg, 30 tablet bottles. The recall is due to Current Good Manufacturing Practice (CGMP) deviations, specifically the presence of an impurity identified as N-Methylnitrosobutyric acid (NMBA). The affected product is distributed by Wal-Mart and manufactured for Camber Pharmaceuticals, Inc.
The recall covers 456,732 bottles with the following lot numbers and expiration dates: 180952 (exp Oct-19), 180953 (exp Dec-19), 181086 (exp Sep-19), and 181572 (exp Jan-20). The product was distributed through Wal-Mart distribution centers in Arkansas, California, Georgia, Indiana, and Maryland.
Consumers who have this medication should contact their healthcare provider for guidance on alternative treatment options. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Losartan Potassium Tablets, USP, 25 mg, 30 tablet bottles, Rx Only, Distributed by: Wal-Mart, Bentonville, AR 72716, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045 NDC 68645-577-54
- Manufacturer
- Legacy Pharmaceutical Packaging LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 456,732
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 (8)
- Lots: 180952
- exp Oct-19
- 180953
- exp Dec-19
- 181086
- exp Sep-19
- 181572
- exp Jan-20
Distribution
Part of a larger recall action
This product is one of 3 recalled by Legacy Pharmaceutical Packaging LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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