Reported Sep 5, 2018 · Terminated
Amlodipine/Valsartan/HCTZ 10mg/320mg/25mg Tablet, Rx Only (HDPE 90cc Bottles in cardboard trays) MFG Torrent Pharma…
RemedyRepack Inc.
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: RemedyRepack Inc. · 625 Kolter Dr Ste 4 · Indiana, PA · 15701-3571
Is this the product you have?
- 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
- Lot codes and dates
70518-1220-0Lot #: B0476653-080218Exp
- Date08/2019
- Amount recalled
- 3 bottles of 90 tablets (270 tablets overall)
Where it was sold
Why it was recalled
CGMP Deviations: Detection of trace amounts of NDMA, a possible impurity or contaminant in an active pharmaceutical ingredient.
This product could cause temporary or reversible health problems — stop using it.
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