GABAPENTIN Recall D-0570-2023
Description: Gabapentin Tablets, USP 600 mg, packaged in Cartons of 100 tablets (10 tablets per blister pack x 10), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. East Windsor, NJ 08520 Distributed by: Major Pharmaceuticals 17177 N Laurel Park Dr., Suite 233 Livonia, MI 48152 USA, NDC 0904-6823-61
GABAPENTIN Recall D-0570-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0570-2023 |
| Event ID | 92174 |
| Brand | GABAPENTIN |
| Generic Name | GABAPENTIN |
| Manufacturer | GABAPENTIN |
| Active Substance | GABAPENTIN |
| Drug Route | ORAL |
| Distribution | USA Nationwide |
| Quantity | 3984 cartons |
| Recall Reason | Product mixup: one foreign tablet found in product. |
| Drug Classification | Class III |
| Drug Code Info | 20230517 |
| Product NDC | 0904-6823 0904-7108 |
| Product NUI | N0000008486 |
| Pharma Class (PE) | Decreased Central Nervous System Disorganized Electrical Activity [PE] |
| Recall Initiation Date | 20230424 |
| Report Date | 20230517 |
| Classification Date | 20230510 |
| Address | 341 Mason Rd La Vergne, TN 37086-3606 United States |
| Recalling Firm | The Harvard Drug Group |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 6CW7F3G59X |
| Drug Application Number | ANDA200651 |
| Structured Product Labeling (SPL ID) | e4dba0e2-e43e-4334-83e7-3db4fcd7f659 |
| Structured Product Labeling (SPL Set ID) | 152adf1d-ec0c-4561-bf80-e4c7da158723 |
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