LIDOCAINE Recall D-0704-2022
Description: Lidocaine Cream 4%, Net Wt. 30 grams tube, Distributed by: RUGBY LABORATORIES, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0536-1281-28.
LIDOCAINE Recall D-0704-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0704-2022 |
| Event ID | 89798 |
| Brand | LIDOCAINE 4% CREAM |
| Generic Name | LIDOCAINE |
| Manufacturer | LIDOCAINE |
| Original Package? | 1 |
| Active Substance | LIDOCAINE |
| Drug Route | TOPICAL |
| Distribution | Nationwide in the USA and Puerto Rico |
| Quantity | 48,907 tubes |
| Recall Reason | cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. |
| Drug Classification | Class II |
| Drug Code Info | 20220330 |
| Product NDC | 0536-1281 |
| 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 | 20220315 |
| Report Date | 20220330 |
| Classification Date | 20220321 |
| Address | 105 Lincoln Avenue Buena, NJ 08310 United States |
| Recalling Firm | Teligent Pharma, Inc. |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 98PI200987 |
| Drug Application Number | part348 |
| Structured Product Labeling (SPL ID) | b83d3c7a-5f3d-445f-aedb-4bb40549688d |
| Structured Product Labeling (SPL Set ID) | 21ea06f4-813e-419e-9b87-1eb04d48097e |
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