Amlodipine and Valsartan Tablets, USP 5/320 mg, 30-count bottles, Rx Only, Made in India, Manufac...
FDA Recall #D-0322-2019 — Class II — December 4, 2018
Product Description
Amlodipine and Valsartan Tablets, USP 5/320 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A., NDC 0378-1723-93.
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
109,314 HDPE bottles
Distribution
Product was distributed throughout the United States to several major distributors, including Puerto Rico.
Code Information
Lot Numbers: 3064086, 3066061, 3066062,3073145,3073146,3073147, 3076091, 3077619, 3082432
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated