Valsartan and Hydrochlorothiazide Tablets, USP 80/12.5 mg, (a) 90-count bottle (NDC 0378-6321-77)...
FDA Recall #D-0328-2019 — Class II — December 4, 2018
Product Description
Valsartan and Hydrochlorothiazide Tablets, USP 80/12.5 mg, (a) 90-count bottle (NDC 0378-6321-77), (b) 500-count bottles (NDC 0378-6321-05), Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A.
Reason for Recall
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Recalling Firm
Mylan Laboratories Limited, (Nashik FDF) — Sinnar, Nashik District, N/A
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
32,696 HDPE bottles
Distribution
Product was distributed throughout the United States to several major distributors, including Puerto Rico.
Code Information
Lot numbers: 3084363, 3084364, 3093800, 3084363, 3093800
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated