Ascend Laboratories LLC Recall: Olmesartan Medoxomil Tablets 20 mg, Rx Only, 90 Tablets pe
Ascend Laboratories LLC Recall: Olmesartan Medoxomil Tablets 20 mg, Rx Only, 90 Tablets pe is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Ascend Laboratories LLC; Product: Olmesartan Medoxomil Tablets 20 mg, Rx Only, 90 Tablets per Bottle, Manufactured by: Alkem Laboratories Ltd., Mum
| Recalling firm | Ascend Laboratories LLC |
|---|---|
| Product | 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 67877-446-90. |
| 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. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | Nationwide in the U.S. |
| Recall initiated | 20200124 |
| Recall number | D-0828-2020 |
| Category | drug |
| State | NJ |
| Country | United States |
$29/mo
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