Recall Enforment Report D-1293-2022

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Jubilant Cadista Pharmaceuticals, Inc., originally initiated on 07-18-2022 for the product 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 The product was recalled due to failed dissolution specifications.. The product was distributed nationwide and the recall is currently terminated.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-1293-202207-18-202208-03-2022Class II9,600 bottlesIrbesartan 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 59746-448-90Failed dissolution specifications.Terminated
D-1294-202207-18-202208-03-2022Class II28,560 bottlesIrbesartan 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 59746-447-90Failed Dissolution SpecificationsTerminated

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
59746-447Irbesartan IrbesartanTabletOralJubilant Cadista Pharmaceuticals Inc.Human Prescription Drug
59746-448Irbesartan IrbesartanTabletOralJubilant Cadista Pharmaceuticals Inc.Human Prescription Drug
59746-449Irbesartan IrbesartanTabletOralJubilant Cadista Pharmaceuticals Inc.Human Prescription Drug