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
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0508-2023 |
| Event ID | 92054 |
| Brand | ALPRAZOLAM |
| Generic Name | ALPRAZOLAM |
| Manufacturer | ALPRAZOLAM |
| Active Substance | ALPRAZOLAM |
| Drug Route | ORAL |
| Distribution | Nationwide in the USA |
| Quantity | 349 bottles |
| Recall Reason | CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer. |
| Drug Classification | Class II |
| Drug Code Info | 20230412 |
| Product NDC | 72189-121 72189-240 72189-213 |
| Product NUI | N0000175694 M0002356 |
| Pharma Class (EPC) | Benzodiazepine [EPC] |
| Pharma Class (CS) | Benzodiazepines [CS] |
| Recall Initiation Date | 20230322 |
| Report Date | 20230412 |
| Classification Date | 20230406 |
| Address | 94 Worldwide Dr Dawsonville, GA 30534-6828 United States |
| Recalling Firm | Direct Rx |
| Initial Notification | Letter |
| Unique Ingredient Identifier | YU55MQ3IZY |
| Drug Application Number | ANDA207507 |
| 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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