LIDOCAINE Recall D-0794-2022
Description: Lidocaine 2.5% and Prilocaine 2.5% Cream, USP, packaged in a) 5 g tubes (NDC 0591-2070-72), b) 30 g tubes (NDC 0591-2070-30), Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310, USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, USA
LIDOCAINE Recall D-0794-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0794-2022 |
| Event ID | 89944 |
| Brand | LIDOCAINE AND PRILOCAINE |
| Generic Name | LIDOCAINE AND PRILOCAINE |
| Manufacturer | LIDOCAINE AND PRILOCAINE |
| Original Package? | 1 |
| Active Substance | LIDOCAINE PRILOCAINE |
| Drug Route | TOPICAL |
| Distribution | Nationwide within the United States |
| Quantity | 353964 units |
| Recall Reason | cGMP Deviations |
| Drug Classification | Class II |
| Drug Code Info | 20220504 |
| Product NDC | 0591-2070 59088-767 |
| Product NUI | N0000175682 M0000897 N0000175426 |
| Drug UPC | 0352817330109 |
| Pharma Class (PE) | Local Anesthesia [PE] |
| Pharma Class (EPC) | Amide Local Anesthetic [EPC] |
| Pharma Class (CS) | Amides [CS] |
| Recall Initiation Date | 20220415 |
| Report Date | 20220504 |
| Classification Date | 20220427 |
| Address | 400 Interpace Pkwy Bldg A Parsippany, NJ 07054-1120 United States |
| Recalling Firm | Teva Pharmaceuticals USA Inc |
| Unique Ingredient Identifier | 98PI200987 046O35D44R |
| Drug Application Number | NDA019941 |
| Structured Product Labeling (SPL ID) | c1d83f9e-e4ab-4d6b-ae19-e08464b4afd1 |
| Structured Product Labeling (SPL Set ID) | 1972d657-2d5a-4697-bba9-80caffc2f2d7 |
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