Reported Aug 29, 2018 · Ongoing
Valsartan and Hydrochlorothiazide Tablets, Valsartan 160 MG and Hydrochlorothiazide 12.5 MG, 90 tablets per bottle, Rx…
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 and Hydrochlorothiazide Tablets, Valsartan 160 MG and Hydrochlorothiazide 12.5 MG, 90 tablets per bottle, Rx Only
- MFGArrow Pharm (Malta) LTD, Birzebbugia, BBG 3000 Malta
- NDC54569-6480-0
- Lot codes and dates
- Expiry
- lot
4/30/2019: 80331307/31/2019: 8068192811018380801578190195
- Amount recalled
- 524 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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