LAMOTRIGINE Recall D-1329-2022
Description: Lamotrigine Tablets, USP 100 mg, 1000-count bottles, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-367-10, UPC 3 42291 36710 4
LAMOTRIGINE Recall D-1329-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1329-2022 |
| Event ID | 90637 |
| Brand | LAMOTRIGINE |
| Generic Name | LAMOTRIGINE |
| Manufacturer | LAMOTRIGINE |
| Active Substance | LAMOTRIGINE |
| Drug Route | ORAL |
| Distribution | Nationwide within the United States |
| Quantity | 8328 bottles |
| Recall Reason | Labeling: Label Error on Declared Strength |
| Drug Classification | Class III |
| Drug Code Info | 20220817 |
| Product NDC | 42291-366 42291-367 42291-368 |
| Product NUI | N0000175753 N0000008486 N0000175751 |
| Drug UPC | 0342291368606 342291367104 |
| Pharma Class (PE) | Decreased Central Nervous System Disorganized Electrical Activity [PE] |
| Pharma Class (EPC) | Anti-epileptic Agent [EPC] |
| Recall Initiation Date | 20220720 |
| Report Date | 20220817 |
| Classification Date | 20220808 |
| Address | 615 N 1st St Pulaski, TN 38478-2403 United States |
| Recalling Firm | AVKARE Inc. |
| Initial Notification | Letter |
| Unique Ingredient Identifier | U3H27498KS |
| Drug Application Number | ANDA079132 |
| Structured Product Labeling (SPL ID) | d57af4f3-6350-5f6c-e053-2995a90a15a4 |
| Structured Product Labeling (SPL Set ID) | fcdb94a8-33be-6375-98ef-6933999d157f |
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