ALPRAZOLAM Recall D-0504-2023
Description: Alprazolam Tab, USP 0.25mg, (CIV), 30-count bottle, Rx Only, Preferred Pharmaceuticals, Inc. Manufactured by: Breckenridge Pharmaceuticals, Inc., Boca Raton, FL. Ins:NDC 68788-7594-3
ALPRAZOLAM Recall D-0504-2023 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | D-0504-2023 |
Event ID | 92008 |
Brand | ALPRAZOLAM |
Generic Name | ALPRAZOLAM |
Manufacturer | ALPRAZOLAM |
Active Substance | ALPRAZOLAM |
Drug Route | ORAL |
Distribution | Nationwide in the USA |
Quantity | 30 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 | 68788-7594 |
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) | bfff34b0-12dc-4ff0-947f-4e3797fc51d8 |
Structured Product Labeling (SPL Set ID) | 01289569-acdc-4213-950d-9c313df4a90a |
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