Amlodipine and Valsartan Tablets USP 10mg/160mg, 30 count bottles, Manufactured for: Aurobindo Ph...
FDA Recall #D-1036-2019 — Class II — December 31, 2018
Product Description
Amlodipine and Valsartan Tablets USP 10mg/160mg, 30 count bottles, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ Manufactured by: Aurobindo Pharma Limited, India --- NDC 65862-739-30
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
Aurobindo Pharma USA Inc. — East Windsor, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
N/A
Distribution
Product was distributed to major distribution chains throughout the United States.
Code Information
Lot Numbers: VFSA17007-A, exp. date Oct-2019
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated