LIDOCAINE Recall D-1047-2022
Description: Lidocaine and Prilocaine Cream, 2.5%/2.5%, 5 gram tubes, Rx only, MFG: Sandoz Pharma, NDC 0168-0357-56
LIDOCAINE Recall D-1047-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1047-2022 |
| Event ID | 89646 |
| Brand | LIDOCAINE AND PRILOCAINE |
| Generic Name | LIDOCAINE AND PRILOCAINE |
| Manufacturer | LIDOCAINE AND PRILOCAINE |
| Original Package? | 1 |
| Active Substance | LIDOCAINE PRILOCAINE |
| Drug Route | TOPICAL |
| Distribution | USA nationwide. |
| Quantity | 23 tubes |
| Recall Reason | cGMP deviations: Temperature abuse |
| Drug Classification | Class II |
| Drug Code Info | 20220615 |
| Product NDC | 0168-0357 |
| Product NUI | N0000175682 M0000897 N0000175426 |
| Drug UPC | 0301680357300 |
| 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 046O35D44R |
| Drug Application Number | ANDA076453 |
| Structured Product Labeling (SPL ID) | 01ee03aa-5444-4e90-9d08-9c3506a3bae0 |
| Structured Product Labeling (SPL Set ID) | 833cd52c-6470-49c4-937f-1393971f4db9 |
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