LIDOCAINE Recall D-0849-2022
Description: Lidocaine Prilocaine Cream USP, 2.5%/2.5% Net Wt. 30 gram tube, Rx Only, Distributed by: McKesson Corporation dba Sky Packaging 4971 Southridge Blvd., Suite 101 Memphis, TN 38141 Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310, NDC 63739-054-66
LIDOCAINE Recall D-0849-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0849-2022 |
| Event ID | 89986 |
| 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 in the United States including Guam and the Northern Mariana Islands. |
| Quantity | 1176 tubes |
| Recall Reason | CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program. |
| Drug Classification | Class II |
| Drug Code Info | 20220511 |
| Product NDC | 63739-054 |
| Product NUI | N0000175682 M0000897 N0000175426 |
| Drug UPC | 0363739054660 |
| Pharma Class (PE) | Local Anesthesia [PE] |
| Pharma Class (EPC) | Amide Local Anesthetic [EPC] |
| Pharma Class (CS) | Amides [CS] |
| Recall Initiation Date | 20220421 |
| Report Date | 20220511 |
| Classification Date | 20220505 |
| Address | 4853 Crumpler Rd Memphis, TN 38141-8301 United States |
| Recalling Firm | McKesson Corporation dba McKesson Drug Company |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 98PI200987 046O35D44R |
| Drug Application Number | ANDA205887 |
| Structured Product Labeling (SPL ID) | 9b924815-f957-45d0-b4b4-44a8c41aa7b8 |
| Structured Product Labeling (SPL Set ID) | f31fc5e2-d7ff-4381-ba23-d4b25e5b430b |
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