Reported Mar 27, 2019 · Ongoing
Valsartan Tablets 160 mg USP, 90 tablet bottles, Rx only, Distributed by: Acetris Health, LLC, Saddle Brook, NJ 07663,…
Rising Pharmaceuticals, 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: Rising Pharmaceuticals, Inc. · 250 Pehle Ave Ste 601 · Saddle Brook, NJ · 07663-5832
Is this the product you have?
Valsartan Tablets 160 mg USP90 tablet bottlesRx only
- Distributed byAcetris Health, LLC, Saddle Brook, NJ 07663
- Manufactured byAurolife Pharma LLC, Dayton, NJ 08810 ---- NDC 52343-124-90
- Lot codes and dates
472180005Bexp. date 02/29/2020 472180011Aexp. date 04/30/2020 472180012Aexp. date 04/30/2020
- Amount recalled
- 35,281 bottles
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Why it was recalled
CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products
This product could cause temporary or reversible health problems — stop using it.
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