LIDOCAINE Recall D-0693-2022
Description: Lidocaine Cream, 4%, packaged in a) Net Wt. 15 grams tubes, NDC 52565-122-15; b) Net Wt. 30 grams tubes, NDC 52565-122-30; c) 5 x 5 gram tubes, NDC 52565-122-07; Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 08310; Manufactured by: Teligent Pharma, Inc., Buena, New Jersey 08310.
LIDOCAINE Recall D-0693-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0693-2022 |
| 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 | 136,960 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 | 52565-122 |
| 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) | a8eeed92-d89f-4119-b862-31e1f91f6b21 |
| Structured Product Labeling (SPL Set ID) | a3216e25-82bb-4905-ac0b-b2ef4aa32ea0 |
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