Product Safety Recalls

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ALPRAZOLAM Recall D-0508-2023

Description: Alprazolam C-IV, 1 mg, packaged in a) 30 Tabs per bottle, NDC 72189-213-30; b) 60 Tabs per bottle, NDC 72189-213-60; Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534.

ALPRAZOLAM Recall D-0508-2023 Information

Mandated?Voluntary: Firm initiated
Recall NumberD-0508-2023
Event ID92054
Active SubstanceALPRAZOLAM
Drug RouteORAL
DistributionNationwide in the USA
Quantity349 bottles
Recall ReasonCGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.
Drug ClassificationClass II
Drug Code Info20230412
Product NDC72189-121 72189-240 72189-213
Product NUIN0000175694 M0002356
Pharma Class (EPC)Benzodiazepine [EPC]
Pharma Class (CS)Benzodiazepines [CS]
Recall Initiation Date20230322
Report Date20230412
Classification Date20230406
Address94 Worldwide Dr
Dawsonville, GA 30534-6828
United States
Recalling FirmDirect Rx
Initial Notification Letter
Unique Ingredient IdentifierYU55MQ3IZY
Drug Application NumberANDA207507
Structured Product Labeling (SPL ID)dc9cd586-9b54-71bd-e053-2a95a90a2c30
Structured Product Labeling (SPL Set ID)ac886819-5bf1-2294-e053-2995a90ad058
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