Reported Aug 1, 2018 · Ongoing
Solco Healthcare US Valsartan, USP, 40 MG Tablets, 30- count bottle, Rx Only, Manufactured by: Zhejiang Huahai…
Prinston Pharmaceutical 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: Prinston Pharmaceutical Inc · 2002 Eastpark Blvd · Cranbury, NJ · 08512-3514
Is this the product you have?
- Solco Healthcare US Valsartan, USP, 40 MG Tablets, 30- count bottle, Rx Only
- Manufactured byZhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024
- China Distributed bySolco Healthcare US, LLC Cranbury, NJ 08512 USA NDC 43547-367-03
- Lot codes and dates
- All lots within expiry.
- Amount recalled
- N/A
This recall covers 9 products
The agency filed one notice per product. You are reading one of them; the other 8 are below.
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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