LIDOCAINE Recall D-0705-2022
Description: Lidocaine Ointment USP, 5%, Net Wt 35.44 g (1 1/4 Oz) tube, Rx Only, Manufactured for: Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701, NDC 50383-341-35.
LIDOCAINE Recall D-0705-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0705-2022 |
| Event ID | 89798 |
| Brand | LIDOCAINE |
| Generic Name | LIDOCAINE |
| Manufacturer | LIDOCAINE |
| Original Package? | 1 |
| Active Substance | LIDOCAINE |
| Drug Route | TOPICAL |
| Distribution | Nationwide in the USA and Puerto Rico |
| Quantity | 49,081 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 | 50383-341 |
| 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 | ANDA205318 |
| Structured Product Labeling (SPL ID) | 148d00de-9bbf-4528-8b9f-23a6274a24e7 |
| Structured Product Labeling (SPL Set ID) | f9303361-534d-4daa-bb4f-29992a0232dc |
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