Drug recall
Ranolazine Extended-Release Tablets 500mg, 60 Tablets per bottle, Rx Only, Manufactured by: Glenmark…
FDA recall event 93263 · Class II · Glenmark Pharmaceuticals Inc., USA
Key facts
| Event ID | 93263 |
|---|---|
| Recall numbers | D-0092-2024 |
| Recalling firm | Glenmark Pharmaceuticals Inc., USA |
| Product type | Drugs |
| Products | Ranolazine Extended-Release Tablets 500mg, 60 Tablets per bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur Dist - Dhar, Madhya… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Failed Dissolution Specifications: Out of specification for dissolution. |
| Initiation date | Oct 23, 2023 |
| Report date | Nov 15, 2023 |
| City | Mahwah |
| State | NJ |
| Country | United States |
| FEI number | 3005658103 |
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: