Irbesartan Tablets, USP, 75 mg, 90- count bottle, Rx only, Manufactured by: Jubilant Generics Ltd...
FDA Recall #D-1294-2022 — Class II — July 18, 2022
Product Description
Irbesartan Tablets, USP, 75 mg, 90- count bottle, Rx only, Manufactured by: Jubilant Generics Ltd. Roorkee- 247661, India, Marketed by: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-447-90
Reason for Recall
Failed Dissolution Specifications
Recalling Firm
Jubilant Cadista Pharmaceuticals, Inc. — Salisbury, MD
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
28,560 bottles
Distribution
Nationwide within the United States
Code Information
Lot #: IB120012A, IB120013A, IB120014A Exp. date 08/2022
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated