Dec. 7, 2018 — Drugmaker Mylan Pharmaceuticals this week announced it has expanded its previous recall of valsartan-based blood pressure medication to include all existing lots of the drug that have not expired.
The expansion includes an additional 104 lots:
26 lots of Amlodipine and Valsartan Tablets, in 5 mg/160 mg, 10 mg/160 mg, 5 mg/320 mg, and 10 mg/320 mg strengths.
51 lots of Valsartan Tablets in 40 mg, 80 mg, 160 mg, and 320 mg strengths.
27 lots of Valsartan and Hydrochlorothiazide Tablets, USP (80 mg/12.5 mg, 160 mg/12.5 mg, 160 mg/25 mg, 320 mg/12.5 mg and 320 mg/25 mg strengths).
The drugs were recalled because of trace amounts of an impurity, N-nitrosodiethylamine, or NDEA, which may cause cancer in humans, according to the International Agency for Research on Cancer.
The latest recall joins many others of recent weeks, all of which were made, or include ingredients made, in China or India.
You can find a comprehensive list of all recalled valsartan products here.
WebMD Article Reviewed by Brunilda Nazario, MD
Sources
FDA.gov: “Mylan Expands Its Voluntary Nationwide Recall of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, to all Lots Within Expiry Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient.”
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