Recalls / Class II
Class IID-1075-2019
Product
Losartan Potassium Tablets, USP, 50 mg, 30 tablet bottles, Rx Only, Distributed by: The Kroger Co, Cincinnati, OH 45202, Manufactured for: Torrent Pharma Inc., 150 Allen Road, Suite 102, Basking Ridge, NJ 07920, Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045 NDC 68645-494-54
- Affected lot / code info
- Lots: 180190, 180191 (exp 10/2020) and 181597 (exp 02/2021)
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
- 179,544 30-count bottles
- Distribution pattern
- AZ, IN, TN
Timeline
- Recall initiated
- 2019-03-01
- FDA classified
- 2019-04-01
- Posted by FDA
- 2019-04-10
- Terminated
- 2023-09-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1075-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.