LIDOCAINE Recall D-0556-2023
Description: Lidocaine Patch 5%, 1 patch (63629-8755-20) packaged in 30-count patches per carton (63629-8755-1), Rx only, each patch contains: 700 mg (50mg per gram adhesive) in an aqueous base, Manufactured by: Actavis Laboratories UT, Inc., Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504 USA
LIDOCAINE Recall D-0556-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0556-2023 |
| Event ID | 92161 |
| Brand | LIDOCAINE |
| Generic Name | LIDOCAINE |
| Manufacturer | LIDOCAINE |
| Active Substance | LIDOCAINE |
| Drug Route | TOPICAL |
| Distribution | Nationwide in the USA |
| Quantity | 403 boxes |
| Recall Reason | Labeling: Typographical error on the upper left-hand side of the box and individual patch label that has the incorrect dosage form stating, each tablet contains instead of each adhesive patch contains. |
| Drug Classification | Class III |
| Drug Code Info | 20230510 |
| Product NDC | 63629-8755 |
| 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 | 20230420 |
| Report Date | 20230510 |
| Classification Date | 20230428 |
| Address | 1919 N Victory Pl Burbank, CA 91504-3425 United States |
| Recalling Firm | Bryant Ranch Prepack, Inc. |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 98PI200987 |
| Drug Application Number | ANDA200675 |
| Structured Product Labeling (SPL ID) | 3213bb03-7987-4a97-8423-708f064d1f2c |
| Structured Product Labeling (SPL Set ID) | 1d28d687-695e-4cd9-97e2-7d4fdab9772a |
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