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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