Reported Mar 27, 2019 · Ongoing
Valsartan Tablets USP 160 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC…
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?
Valsartan Tablets USP 160 mg90 count bottlesRx only
- Distributed byAurobindo Pharma USA, Inc., Dayton, NJ --- NDC 65862-572-90
- Lot codes and dates
- Lot Numbers
472180001A472180002A472180003A472180004Aexp. date Jan 2020472180007A472180008A472180009A472180010Aexp. date Mar 2020472180013A472180014Aexp. date Apr 2020
- Lot Numbers
- Amount recalled
- N/A
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Why it was recalled
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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