Valsartan Tablets USP, 40 mg, 30-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd Ro...
FDA Recall #D-1103-2018 — Class III — August 14, 2018
Product Description
Valsartan Tablets USP, 40 mg, 30-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd Roorkee 0247661 India, Marketed by: Jubilant Cardista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-360-30
Reason for Recall
Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
Recalling Firm
Jubilant Cadista Pharmaceuticals, Inc. — Salisbury, MD
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
10,577 bottles
Distribution
Product was distributed throughout the United States to wholesalers and retailers.
Code Information
Lot #: VR117014A, VR117015A, Exp. 08/2019
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated