RemedyRepack Inc. recalls Amlodipine/Valsartan/HCTZ 10mg/320mg/25mg Tablet, Rx Only (HDPE 90cc Bottles in cardboard trays) MFG Torrent Pharma LTD,
Recalled September 5, 2018 · FDA recall D-1146-2018 · RemedyRepack
Hazard
CGMP Deviations: Detection of trace amounts of NDMA, a possible impurity or contaminant in an active pharmaceutical ingredient. · FDA Class II
Units
3 bottles of 90 tablets (270 tablets overall)
Sold at
South Carolina
Description
CGMP Deviations: Detection of trace amounts of NDMA, a possible impurity or contaminant in an active pharmaceutical ingredient.
Product
Amlodipine/Valsartan/HCTZ 10mg/320mg/25mg Tablet, Rx Only (HDPE 90cc Bottles in cardboard trays) MFG Torrent Pharma LTD, Indrad, India 38272, NDC #70518-1220-0
Manufacturer(s)
RemedyRepack Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →