Reported Apr 10, 2019 · Terminated
Losartan Potassium Tablets, USP, 50 mg, 30 tablet bottles, Rx Only, Distributed by: The Kroger Co, Cincinnati, OH…
Legacy Pharmaceutical Packaging LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Legacy Pharmaceutical Packaging LLC · 13333 Lakefront Dr · Earth City, MO · 63045-1514
Is this the product you have?
- Losartan Potassium Tablets, USP, 50 mg, 30 tablet bottles, Rx Only
- Distributed byThe Kroger Co, Cincinnati, OH 45202
- Manufactured for
Torrent Pharma Inc150 Allen RoadSuite 102Basking RidgeNJ 07920
- Packaged byLegacy Pharmaceutical Packaging LLC, Earth City, MO 63045 NDC 68645-494-54
- Lot codes and dates
- Lots180190, 180191 (exp 10/2020) and 181597 (exp 02/2021)
- Amount recalled
- 179,544 30-count bottles
Where it was sold
Why it was recalled
CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected.
This product could cause temporary or reversible health problems — stop using it.
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