Valsartan Tablets, USP 320 mg, 90-count bottles, Rx Only, Made in India, Manufactured for: Mylan ...
FDA Recall #D-0327-2019 — Class II — December 4, 2018
Product Description
Valsartan Tablets, USP 320 mg, 90-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. NDC 0378-5815-77.
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
129,754 HDPE bottles
Distribution
Product was distributed throughout the United States to several major distributors, including Puerto Rico.
Code Information
Lot Numbers: 3063783 3063784 3063785 3064092 3064093 3064094 3070349 3070350 3070351 3070352 3070353 3070354 3079030 3079031 3079032 3079033 3080011 3080224 3081498 3081500 3087126 3088476
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated