Losartan Potassium Tablets recall: Impurity Out of Spec
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 63045 NDC 68645-494-54
Why was Losartan Potassium Tablets recalled?
CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lots: 180190, 180191 (exp 10/2020) and 181597 (exp 02/2021)
- 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 63045 NDC 68645-494-54
- Recalling firm
- Legacy Pharmaceutical Packaging LLC
- Quantity
- 179,544 30-count bottles
- Distribution
- AZ, IN, TN
- Recall date
- April 10, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)