Reported Oct 31, 2018 · Terminated
Amlodipine/Valsartan HCTZ 10 mg/320 mg/25 mg tablets, HDPE 90 cc bottles in cardboard trays Original NDC 13668-0325-30…
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 10 mg/320 mg/25 mg tablets, HDPE 90 cc bottles in cardboard trays Original NDC 13668-0325-30 Repackaged NDC 70518-1220-00
- Lot codes and dates
- Lot # B0438903-052118 70518-1220-00
- Amount recalled
- 2 bottles of 90 tablets (180 tablets)
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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