Reported Jan 23, 2019 · Ongoing
Amlodipine and Valsartan Tablets USP 5 mg/320 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA,…
Aurobindo Pharma USA 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: Aurobindo Pharma USA Inc. · 279 Princeton Hightstown Rd · East Windsor, NJ · 08520-1401
Is this the product you have?
- Amlodipine and Valsartan Tablets USP 5 mg/320 mg, 30-count bottles, Rx Only
- Manufactured forAurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-738-30
- Lot codes and dates
6 of 6 products
Products covered by this recall # Product as published 1 Lot # VMSA17012-A, exp. date 11/2019 2 Lot # VMSA17013-A, exp. date 11/2019 3 Lot # VMSA17014-A, exp. date 11/2019 4 Lot # VMSA17015-A, exp. date 11/2019 5 Lot # VMSA17016-A, exp. date 11/2019 6 Lot # VMSA17017-A, exp. date 11/2019 - Amount recalled
- 27,688 bottles
This recall covers 10 products
The agency filed one notice per product. You are reading one of them; the other 9 are below.
Why it was recalled
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
This product could cause temporary or reversible health problems — stop using it.
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