Tetracaine Injection Recalled for Sterility Assurance Manufacturing Defect
Tetracaine 1% Injectable is being recalled due to sterility assurance failures caused by manufacturing deviations that may compromise product sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving a sterility defect in an injectable drug. No hospitalizations or illnesses have been reported. The hazard is theoretical—manufacturing deviations have compromised assurance of sterility, but actual contamination and harm have not yet been confirmed. Per the rubric, this qualifies as High severity due to being a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Vitae Enim Vitae Scientific, Inc. is recalling Tetracaine 1% Tetracaine HCI Injection, USP (20mg/2mL, 10mg/mL) distributed nationwide. The affected product consists of 10 x 2mL single-use vials per box, manufactured for Cameron Pharmaceuticals, LLC, with NDC 42494-437-10. Lot numbers 21VTHI017, 21VTHI018, and 21VTHI019 with expiration date 5/31/2023 are included in the recall. A total of 722 boxes have been distributed.
The FDA has determined that the manufacturer failed to maintain Current Good Manufacturing Practices (CGMP), resulting in a lack of assurance of sterility. Because tetracaine is an injectable drug that must be sterile to be safe for use, these deviations call into question the sterility of the recalled products.
Healthcare providers and facilities with these recalled lots should contact the manufacturer or their supplier for guidance on handling these products. Patients who received injections from these lots may wish to consult their healthcare provider regarding any potential concerns.
The recalled product
- 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.
- Manufacturer
- Vitae Enim Vitae Scientific, Inc.
- Category
- Drug — Injectable
- Hazard
- sterility-failure
- manufacturing-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot #: 21VTHI017
- 21VTHI018
- 21VTHI019
- Exp 5/31/2023
Distribution
Distributed nationwide across the United States.
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