Reported Aug 22, 2018 · Terminated
Valsartan 160 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 160 mg Tablets, HDPE 90 cc bottles in cardboard trays, Rx Only, RemedyRepack, Inc., 625 Kolter Drive, Suite 4, Indiana, PA 15701
- NDC61786-0792-19
- Lot codes and dates
6 of 6 products
Products covered by this recall # Product as published 1 Lot # B0335344-081717, exp. date 08/2018 2 Lot # B0363364-110917, exp. date 11/2018 3 Lot # B0391225-012218, exp. date 01/2019 4 Lot # B0408458-030618, exp. date 03/2019 5 Lot # B0384871-010318, exp. date 01/2019 6 Lot # B0436862-051518, exp. date 05/2019 - Amount recalled
- 21 bottles of 90 = 1890 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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