Recalls / Class II
Class IID-1048-2019
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
- Affected lot / code info
- Lots: 180952, exp Oct-19, 180953, exp Dec-19, 181086, exp Sep-19, 181572, exp Jan-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
- 456,732 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-1048-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.