Recalls / Class II

Class IID-1050-2019

Product

Losartan Potassium Tablets, USP, 100 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 68645-579-54

Affected lot / code info

180886, Nov-19; 180887, 180888, 180905, Dec-19; 181123, Sep-2019; 181124, Oct-2019, 181125, Aug-19, 181351, Nov-19, 181352, Dec-19, 181551, Nov-19, 181628, 181629, 181727, 181728, Jun-20; 181890, Mar-20; 181891, 181897, Jun-20; 182114, Mar-20; 182119, 182120, Jun-20

Why it was recalled

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

Recalling firm

Firm

Legacy Pharmaceutical Packaging LLC

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

13333 Lakefront Dr, N/A, Earth City, Missouri 63045-1514

Distribution

Quantity

2,497,856 bottles

Distribution pattern

Wal-Mart distribution centers in AR, CA, GA, IN and MD

Timeline

Recall initiated

2019-03-01

FDA classified

2019-03-21

Posted by FDA

2019-03-27

Status

Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-1050-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.