TETRACAINE HYDROCHLORIDE Recall D-0741-2022
Description: TETRACAINE 1% Tetracaine HCI Injection, USP, 20mg/2mL (10mg/mL), 10 x 2ml Single Use Vials per box, Rx only, Manufactured for Cameron Pharmaceuticals, LLC., NDC 42494-437-10.
TETRACAINE HYDROCHLORIDE Recall D-0741-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0741-2022 |
| Event ID | 89803 |
| Brand | TETRACAINE |
| Generic Name | TETRACAINE HYDROCHLORIDE |
| Manufacturer | TETRACAINE HYDROCHLORIDE |
| Original Package? | 1 |
| Active Substance | TETRACAINE HYDROCHLORIDE |
| Drug Route | ORAL |
| Distribution | Nationwide in the U.S.A |
| Quantity | 722 boxes |
| Recall Reason | Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile. |
| Drug Classification | Class II |
| Drug Code Info | 20220413 |
| Product NDC | 42494-437 |
| Recall Initiation Date | 20220314 |
| Report Date | 20220413 |
| Classification Date | 20220405 |
| Address | 3030 Bunker Hill St Ste 203 San Diego, CA 92109-5754 United States |
| Recalling Firm | Vitae Enim Vitae Scientific, Inc. |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
| Unique Ingredient Identifier | 5NF5D4OPCI |
| Structured Product Labeling (SPL ID) | c513e659-6c72-43d2-b46c-27cf9a0e3f79 |
| Structured Product Labeling (SPL Set ID) | 80a96844-f983-4852-8197-a46a5f60461d |
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