Drug recall
Irbesartan Tablets, USP, 150mg, 90- count bottles, Rx only, Manufactured by: Jubilant Generics Ltd. Roorkee…
FDA recall event 90610 · Class II · Jubilant Cadista Pharmaceuticals, Inc.
Key facts
| Event ID | 90610 |
|---|---|
| Recall numbers | D-1293-2022, D-1294-2022 |
| Recalling firm | Jubilant Cadista Pharmaceuticals, Inc. |
| Product type | Drugs |
| Products | 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…, 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Failed dissolution specifications., Failed Dissolution Specifications |
| Initiation date | Jul 18, 2022 |
| Report date | Aug 3, 2022 |
| Termination date | Nov 22, 2022 |
| City | Salisbury |
| State | MD |
| Country | United States |
| FEI number | 1000513046 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: