Drug recall
Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg, 90 count bottle, Rx Only, Manufactured by Jubilant…
FDA recall event 85181 · Class II · Jubilant Cadista Pharmaceuticals, Inc.
Key facts
| Event ID | 85181 |
|---|---|
| Recall numbers | D-1058-2020 |
| Recalling firm | Jubilant Cadista Pharmaceuticals, Inc. |
| Product type | Drugs |
| Products | Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg, 90 count bottle, Rx Only, Manufactured by Jubilant Generics Ltd, Roorkee-247661 India, NDC 59746-284-90 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | CGMP Deviations: Presence of dark brown discoloration on edges of tablets |
| Initiation date | Mar 11, 2020 |
| Report date | Mar 25, 2020 |
| Termination date | Jun 10, 2020 |
| 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: