Reported Aug 29, 2018 · Ongoing
Valsartan Tablets, 80 MG, 30-count bottle (NDC 54569-6582-0, 90-count bottle (NDC 54569-6582-1), Rx Only, MFG: Zhejiang…
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 Tablets80 MG30-count bottle (NDC 54569-6582-090-count bottle (NDC 54569-6582-1)Rx Only
- MFGZhejiang Huahai Pharma, Linhai, Zhejiang 317024 China
- Lot codes and dates
- Expiry
- lot
[30-count] 11/30/2018: 725817772762282/28/2019: 7212260[90-count] 11/30/2018: 72081402/28/2019: 7212261722115572221618/31/2019: 81091719/30/2019: 8109170
- Amount recalled
- 178 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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