Drug recall
Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg*, 90-count bottle, Rx only, Manufactured by: Jubilant…
FDA recall event 81162 · Class II · Jubilant Cadista Pharmaceuticals, Inc.
Key facts
| Event ID | 81162 |
|---|---|
| Recall numbers | D-0011-2019 |
| 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; Marketed by: Jubilant Cadista Pharmaceuticals… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Discoloration: Presence of dark discoloration or brown spots on the edges of the tablets. |
| Initiation date | Oct 2, 2018 |
| Report date | Oct 17, 2018 |
| Termination date | Feb 24, 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: