PlainRecalls
FDA Drug Moderate Class II Ongoing

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

Reported: March 27, 2019 Initiated: March 1, 2019 #D-1048-2019

Product Description

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

Reason for Recall

CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected

Details

Units Affected
456,732 bottles
Distribution
Wal-Mart distribution centers in AR, CA, GA, IN and MD
Location
Earth City, MO

Frequently Asked Questions

What product was recalled?
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. Recalled by Legacy Pharmaceutical Packaging LLC. Units affected: 456,732 bottles.
Why was this product recalled?
CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected
Which agency issued this recall?
This recall was issued by the FDA Drug on March 27, 2019. Severity: Moderate. Recall number: D-1048-2019.