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-1293-2022 | 07-18-2022 | 08-03-2022 | Class II | 9,600 bottles | 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 | Failed dissolution specifications. | Terminated |
D-1294-2022 | 07-18-2022 | 08-03-2022 | Class II | 28,560 bottles | 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 | Failed Dissolution Specifications | Terminated |
Recalled Products