FDA Drug recall D-0741-2022
TETRACAINE 1% Tetracaine HCI Injection, USP, 20mg/2mL (10mg/mL), 10 x 2ml Single Use Vials per box, Rx only, Manufactured for Cameron Pharm…
- FDA Drug
- Class II
- terminated
- Published 2022-04-13
On 2022-04-13 the FDA classified a Class II recall of TETRACAINE 1% Tetracaine HCI Injection, USP, 20mg/2mL (10mg/mL), 10 x 2ml Single Use Vials per box, Rx only, Manufactured for Cameron Pharm… by Vitae Enim Vitae Scientific, citing lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0741-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-03-14 |
| Published | 2022-04-13 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Vitae Enim Vitae Scientific |
| Distribution | US |
Product
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.
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.
Identifiers
| code_info | Lot #: 21VTHI017, 21VTHI018, 21VTHI019, Exp 5/31/2023 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0741-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.