ALPRAZOLAM Recall D-0844-2022
Description: alprazolam XR extended-release tablets, 3 mg, 60-count bottle, Rx only, Distributed by: Greenstone LLC, Peapack, NJ 07977, NDC 59762-0068-1.
ALPRAZOLAM Recall D-0844-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0844-2022 |
| Event ID | 90045 |
| Brand | ALPRAZOLAM |
| Generic Name | ALPRAZOLAM |
| Manufacturer | ALPRAZOLAM |
| Original Package? | 1 |
| Active Substance | ALPRAZOLAM |
| Drug Route | ORAL |
| Distribution | Product was distributed nationwide in the USA |
| Quantity | 6,789 bottles |
| Recall Reason | Failed Dissolution Specifications: low out-of-specification dissolution test results observed. |
| Drug Classification | Class II |
| Drug Code Info | 20220511 |
| Product NDC | 59762-0057 59762-0059 59762-0066 |
| Product NUI | N0000175694 M0002356 |
| Drug UPC | 0359762005717 0359762005915 0359762006615 |
| Pharma Class (EPC) | Benzodiazepine [EPC] |
| Pharma Class (CS) | Benzodiazepines [CS] |
| Recall Initiation Date | 20220428 |
| Report Date | 20220511 |
| Classification Date | 20220503 |
| Address | 1000 Mylan Blvd Canonsburg, PA 15317-5853 United States |
| Recalling Firm | Viatris Inc |
| Initial Notification | Letter |
| Unique Ingredient Identifier | YU55MQ3IZY |
| Drug Application Number | NDA021434 |
| Structured Product Labeling (SPL ID) | b61cc8c8-f45f-467e-9685-5a7ca43379f4 |
| Structured Product Labeling (SPL Set ID) | 1338d1c9-7c75-42ed-95f3-9eb1b6fc51d3 |
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