LIDOCAINE Recall D-1043-2022
Description: Lidocaine Patch 5%, 30-count carton, Rx only, MFG: Qualitest Products, NDC 0603-1880-16
LIDOCAINE Recall D-1043-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1043-2022 |
| Event ID | 89646 |
| Brand | LIDOCAINE |
| Generic Name | LIDOCAINE |
| Manufacturer | LIDOCAINE |
| Original Package? | 1 |
| Active Substance | LIDOCAINE |
| Drug Route | CUTANEOUS |
| Distribution | USA nationwide. |
| Quantity | 3 cartons/30 pouches per carton |
| Recall Reason | cGMP deviations: Temperature abuse |
| Drug Classification | Class II |
| Drug Code Info | 20220615 |
| Product NDC | 0603-1880 |
| Product NUI | N0000175682 M0000897 N0000175426 |
| Pharma Class (PE) | Local Anesthesia [PE] |
| Pharma Class (EPC) | Amide Local Anesthetic [EPC] |
| Pharma Class (CS) | Amides [CS] |
| Recall Initiation Date | 20220413 |
| Report Date | 20220615 |
| Classification Date | 20220609 |
| Address | 9954 Maryland DriveDeep Run Iii Ste. 4000 Richmond, VA 23233 United States |
| Recalling Firm | Mckesson Medical-Surgical Inc. Corporate Office |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 98PI200987 |
| Drug Application Number | NDA020612 |
| Structured Product Labeling (SPL ID) | 8730a197-a228-4913-815c-c135b1097fd7 |
| Structured Product Labeling (SPL Set ID) | 2ce8a4fe-8aa6-4dc5-ad0f-3984ae68c4bc |
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