Irbesartan Tablets, USP, 150mg, 90- count bottles, Rx only, Manufactured by: Jubilant Generics Lt...
FDA Recall #D-1293-2022 — Class II — July 18, 2022
Product Description
Irbesartan Tablets, USP, 150mg, 90- count bottles, Rx only, Manufactured by: Jubilant Generics Ltd. Roorkee- 247661, India, Marketed by: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-448-90
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
9,600 bottles
Distribution
Nationwide within the United States
Code Information
Lot #: IB220023A, exp. date 08/2022
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated