FDA-Drug2019-04-10Class II
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
Legacy Pharmaceutical Packaging LLC
Hazard
CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected.
Sold states
AZ, IN, TN
Affected count
179,544 30-count bottles
Manufactured in
13333 Lakefront Dr, N/A, Earth City, MO, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1075-2019Don't want to check this manually?
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