DIVALPROEX SODIUM Recall D-1291-2022
Description: Divalproex Sodium Delayed-Release Tablets, USP 500mg, Rx Only, 100 Tablets, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries, Ltd., Halol-Baroda Highway, Halol- 389 350, Gujarat, India, NDC 62756-798-88.
DIVALPROEX SODIUM Recall D-1291-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1291-2022 |
| Event ID | 90495 |
| Brand | DIVALPROEX SODIUM |
| Generic Name | DIVALPROEX SODIUM |
| Manufacturer | DIVALPROEX SODIUM |
| Original Package? | 1 |
| Active Substance | DIVALPROEX SODIUM |
| Drug Route | ORAL |
| Distribution | Nationwide in the USA |
| Quantity | 9552 bottles |
| Recall Reason | Failed Dissolution Specifications: Failure occurred during routine stability testing of dissolution test. |
| Drug Classification | Class II |
| Drug Code Info | 20220803 |
| Product NDC | 62756-796 62756-797 62756-798 |
| Drug UPC | 0362756796836 0362756798830 |
| Recall Initiation Date | 20220627 |
| Report Date | 20220803 |
| Classification Date | 20220726 |
| Address | 2 Independence Way Princeton, NJ 08540-6620 United States |
| Recalling Firm | SUN PHARMACEUTICAL INDUSTRIES INC |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 644VL95AO6 |
| Drug Application Number | ANDA078597 |
| Structured Product Labeling (SPL ID) | aae406af-8556-4667-9ea6-6bc8b3ed2d51 |
| Structured Product Labeling (SPL Set ID) | 64797788-fdcb-4d12-a1a4-743ad71bd17b |
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