Recalls / Class II
Class IID-1049-2019
Product
Losartan Potassium Tablets, USP, 50 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 68645-578-54
- Affected lot / code info
- Lots: 180921, exp Sep-19, 180922, exp Oct-19, 180923, 180924, 181118, exp Nov-19, 181119, exp Oct-19, 181407, exp Nov-19, 181408, exp Dec-19, 181573, 181725, 181726, exp Feb-20, 181948, exp Mar-20, 181960, exp Feb-20, 182385, 182386, 182387, exp Mar-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
- 2,851,284 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-1049-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.