FDAClass IIMarch 27, 2019

Losartan Potassium Tablets recall: Impurity Out of Spec

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

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?

The recall is ongoing. Follow the firm and FDA 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: 180952, exp Oct-19, 180953, exp Dec-19, 181086, exp Sep-19, 181572, exp Jan-20

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
Recalling firm
Legacy Pharmaceutical Packaging LLC
Quantity
456,732 bottles
Distribution
Wal-Mart distribution centers in AR, CA, GA, IN and MD
Recall date
March 27, 2019
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
Open FDA enforcement record Latest recalls