FDA-Drug2019-05-08Class II
Losartan Potassium/HCTZ, 100 mg/12.5 mg Tablet, 90-Count bottle, Manufactured by Torrent Pharmaceuticals, Distributed by RemedyRepack, Inc. Indiana, PA, 15701-3570, NDC 70518-1560-00.
RemedyRepack Inc.
Hazard
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 0.96 parts per million.
Sold states
Product was distributed to Florida.
Affected count
44 HDPE bottles of 90 = 3,960 tablets
Manufactured in
625 Kolter Dr Ste 4, N/A, Indiana, PA, United States
Products
Losartan Potassium/HCTZ, 100 mg/12.5 mg Tablet, 90-Count bottle, Manufactured by Torrent Pharmaceuticals, Distributed by RemedyRepack, Inc. Indiana, PA, 15701-3570, NDC 70518-1560-00.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1270-2019Don't want to check this manually?
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