Drug recall
Olmesartan Medoxomil Tablets 20 mg, Rx Only, 90 Tablets per Bottle, Manufactured by: Alkem Laboratories Ltd…
FDA recall event 84818 · Class II · Ascend Laboratories LLC
Key facts
| Event ID | 84818 |
|---|---|
| Recall numbers | D-0828-2020 |
| Recalling firm | Ascend Laboratories LLC |
| Product type | Drugs |
| Products | Olmesartan Medoxomil Tablets 20 mg, Rx Only, 90 Tablets per Bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013 INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054, NDC… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | cGMP Deviations; Olmesartan Medoximil Tablets 20 mg was released in error with alternate API source prior to filing and approval of Prior Approval Supplement. |
| Initiation date | Jan 24, 2020 |
| Report date | Feb 12, 2020 |
| Termination date | Oct 29, 2021 |
| City | Parsippany |
| State | NJ |
| Country | United States |
| FEI number | 3004459274 |
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: