ALPRAZOLAM Recall D-0506-2023
Description: Alprazolam Tab, USP 1mg, (CIV), packaged in: a) 30-count bottle (NDC 68788-7596-3), b) 60-count bottle (NDC68788-7596-6); Rx Only, Preferred Pharmaceuticals, Inc. Manufactured by: Breckenridge Pharmaceuticals, Inc., Boca Raton, FL.
ALPRAZOLAM Recall D-0506-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0506-2023 |
| Event ID | 92008 |
| Brand | ALPRAZOLAM |
| Generic Name | ALPRAZOLAM |
| Manufacturer | ALPRAZOLAM |
| Active Substance | ALPRAZOLAM |
| Drug Route | ORAL |
| Distribution | Nationwide in the USA |
| Quantity | 33 x 30-count; 78 x 60-count bottles |
| Recall Reason | CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk of Cross Contamination. |
| Drug Classification | Class II |
| Drug Code Info | 20230412 |
| Product NDC | 68788-7596 |
| Product NUI | N0000175694 M0002356 |
| Pharma Class (EPC) | Benzodiazepine [EPC] |
| Pharma Class (CS) | Benzodiazepines [CS] |
| Recall Initiation Date | 20230327 |
| Report Date | 20230412 |
| Classification Date | 20230405 |
| Address | 1250 N Lakeview Ave Ste O Anaheim, CA 92807-1801 United States |
| Recalling Firm | Preferred Pharmaceuticals, Inc. |
| Initial Notification | Letter |
| Unique Ingredient Identifier | YU55MQ3IZY |
| Drug Application Number | ANDA207507 |
| Structured Product Labeling (SPL ID) | b0f5e512-a094-42a4-9c39-9f6eb1353a6a |
| Structured Product Labeling (SPL Set ID) | c3bb1d6e-241c-4c0d-8522-bc5f0ef80fce |
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