Reported Aug 22, 2018 · Terminated
Valsartan 320 mg Tablets, HDPE 90 cc bottles in cardboard trays, Rx Only, RemedyRepack, Inc., 625 Kolter Drive, Suite…
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?
Valsartan 320 mg TabletsHDPE 90 cc bottles in cardboard traysRx OnlyRemedyRepackInc625 Kolter DriveSuite 4IndianaPA 15701NDC 61786-0793-19
- Lot codes and dates
Lot # B0362988-110917exp. date 10/2018 Lot # B0432265-050318exp. date 05/2019 Lot # B0450321-061218exp. date 06/2019 Lot # B0450322-061218exp. date 05/2019 Lot # B0408652-030718exp. date 02/2019
- Amount recalled
- 36 bottles of 90 = 3240 tablets
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug 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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