ZOLPIDEM TARTRATE Recall D-0272-2024
Description: Zolpidem Tartrate Extended-Release Tablets, USP 12.5mg, Rx Only, 100 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), INDIA, NDC 47335-308-88.
ZOLPIDEM TARTRATE Recall D-0272-2024 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0272-2024 |
| Event ID | 93820 |
| Brand | ZOLPIDEM TARTRATE |
| Generic Name | ZOLPIDEM TARTRATE |
| Manufacturer | ZOLPIDEM TARTRATE |
| Original Package? | 1 |
| Active Substance | ZOLPIDEM TARTRATE |
| Drug Route | ORAL |
| Distribution | Nationwide in the USA |
| Quantity | 14,568 bottles |
| Recall Reason | CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment. |
| Drug Classification | Class II |
| Drug Code Info | 20240131 |
| Product NDC | 47335-307 47335-308 |
| Drug UPC | 0347335307887 0347335308884 |
| Recall Initiation Date | 20240118 |
| Report Date | 20240131 |
| Classification Date | 20240125 |
| Address | 2 Independence Way Princeton, NJ 08540-6620 United States |
| Recalling Firm | SUN PHARMACEUTICAL INDUSTRIES INC |
| Initial Notification | Letter |
| Unique Ingredient Identifier | WY6W63843K |
| Drug Application Number | ANDA204170 |
| Structured Product Labeling (SPL ID) | 4a5c474b-e752-4d01-be37-a66e7c9bf62e |
| Structured Product Labeling (SPL Set ID) | 0c64bc71-2e7f-4b15-a8e1-acb8de04395f |
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