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

Mandated?Voluntary: Firm initiated
Recall NumberD-0844-2022
Event ID90045
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
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