Recalls / Class II
Class IID-0741-2022
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.
- Affected lot / code info
- Lot #: 21VTHI017, 21VTHI018, 21VTHI019, Exp 5/31/2023
Why it was recalled
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Recalling firm
- Firm
- Vitae Enim Vitae Scientific, Inc.
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 3030 Bunker Hill St Ste 203, San Diego, California 92109-5754
Distribution
- Quantity
- 722 boxes
- Distribution pattern
- Nationwide in the U.S.A
Timeline
- Recall initiated
- 2022-03-14
- FDA classified
- 2022-04-05
- Posted by FDA
- 2022-04-13
- Terminated
- 2024-08-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0741-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.