FDAJuly 17, 2018drug
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
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
What to do
FDA enforcement status: Ongoing
Brands named
a s medication solutions
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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