Amlodipine and Valsartan Tablets, USP,10 mg/160 mg, 30-count bottle, Rx Only, Made in India, Manu...
FDA Recall #D-0312-2019 — Class II — November 20, 2018
Product Description
Amlodipine and Valsartan Tablets, USP,10 mg/160 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-1722-93.
Reason for Recall
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Recalling Firm
Mylan Pharmaceuticals Inc. — Morgantown, WV
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
12,336 bottles
Distribution
Product was distributed throughout the United States.
Code Information
Lot # 3079500, exp. date 1/2020
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated