Reported Aug 29, 2018 · Ongoing
Valsartan Tablets, 160 MG, 30-count bottle (NDC 54569-6583-0), 90-count bottle (NDC 54569-6583-1), Rx Only, MFG:…
A-S Medication Solutions LLC.
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: A-S Medication Solutions LLC. · 2401 Commerce Dr · Libertyville, IL · 60048-4464
Is this the product you have?
Valsartan Tablets160 MG30-count bottle (NDC 54569-6583-0)90-count bottle (NDC 54569-6583-1)Rx Only
- MFGZhejiang Huahai Pharma, Linhai, Zhejiang 317024 China
- Lot codes and dates
- Expiry
- lot
[30-count] 2/28/2019: 72851773/31/2019: 722216372271758/31/2019: 81621908183227. [90-count] 2/28/2019: 7207135721228072150733/31/2019: 72221628/31/2019: 80952488095249
- Amount recalled
- 666 bottles
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
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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