FDA-Drug2018-09-05Class II
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
RemedyRepack Inc.
Hazard
CGMP Deviations: Detection of trace amounts of NDMA, a possible impurity or contaminant in an active pharmaceutical ingredient.
Sold states
South Carolina
Affected count
3 bottles of 90 tablets (270 tablets overall)
Manufactured in
625 Kolter Dr Ste 4, N/A, Indiana, PA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1146-2018Don't want to check this manually?
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