Valsartan and Hydrochlorothiazide Tablets recalled over manufacturing violations
- Recall date
- July 17, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- A-S Medication Solutions LLC. recalls Valsartan and Hydrochlorothiazide Tablets, Valsartan 160 MG and Hydrochlorothiazide 12.5 MG, 90 tablets per bottle, Rx…
- Recall number
- D-1110-2018
- FDA classification
- Class II
- Brand / firm
- A-S Medication Solutions LLC.
- Sold / distributed
- Nationwide USA
Why it was recalled
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Valsartan and Hydrochlorothiazide Tablets, Valsartan 160 MG and Hydrochlorothiazide 12.5 MG, 90 tablets per bottle, Rx Only, MFG: Arrow Pharm (Malta) LTD, Birzebbugia, BBG 3000 Malta. NDC: 54569-6480-0
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