Product Safety Recalls

Product Recall Tracker

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

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0844-2022
Event ID90045
BrandALPRAZOLAM
Generic NameALPRAZOLAM
ManufacturerALPRAZOLAM
Original Package?1
Active SubstanceALPRAZOLAM
Drug RouteORAL
DistributionProduct was distributed nationwide in the USA
Quantity6,789 bottles
Recall ReasonFailed Dissolution Specifications: low out-of-specification dissolution test results observed.
Drug ClassificationClass II
Drug Code Info20220511
Product NDC59762-0057 59762-0059 59762-0066
Product NUIN0000175694 M0002356
Drug UPC0359762005717 0359762005915 0359762006615
Pharma Class (EPC)Benzodiazepine [EPC]
Pharma Class (CS)Benzodiazepines [CS]
Recall Initiation Date20220428
Report Date20220511
Classification Date20220503
Address1000 Mylan Blvd
Canonsburg, PA 15317-5853
United States
Recalling FirmViatris Inc
Initial Notification Letter
Unique Ingredient IdentifierYU55MQ3IZY
Drug Application NumberNDA021434
Structured Product Labeling (SPL ID)b61cc8c8-f45f-467e-9685-5a7ca43379f4
Structured Product Labeling (SPL Set ID)1338d1c9-7c75-42ed-95f3-9eb1b6fc51d3
Similar To

© 2021 Recall.Report / Contact / Privacy Policy

This site's data is aggregated programmatically and provided "as is" without any representations or warranties, express or implied.
Recall.report is not affiliated with the Consumer Product Safety Commision, FDA, or US government in any way.