CLASS II Drug recall · Reported 13 Apr 2022 · FDA Enforcement Report
Tetracaine 1% Tetracaine HCI Injection, USP, 20mg recalled
Vitae Enim Vitae Scientific is recalling Tetracaine 1% Tetracaine HCI Injection, USP, 20mg/ (10mg/mL), 10 x Single Use Vials per, distributed nationwide in the US. The recall was initiated on 14 Mar 2022 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0741-2022
- FDA event ID
- 89803
- Recalling firm
- Vitae Enim Vitae Scientific, San Diego, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 14 Mar 2022
- FDA classified
- 5 Apr 2022
- Reported
- 13 Apr 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 14 Mar 2022 | Recall initiated by company | |
| 5 Apr 2022 | Classified by FDA | +22 days |
| 13 Apr 2022 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
Nationwide in the U.S.A
Questions about this recall
Why was it 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.
Which lots are affected?
Lot #: 21VTHI017, 21VTHI018, 21VTHI019, Exp 5/31/2023
Where was it sold?
Nationwide in the U.S.A
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 89803| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Phenobarbital Sodium Injection, USP, 65mg/mL recalledPhenobarbital Sodium | Vitae Enim Vitae Scientific | Sterility | Nationwide | |
| CLASS II | Phenobarbital Sodium Injection, USP, 130 mg/mL recalledPhenobarbital Sodium | Vitae Enim Vitae Scientific | Sterility | Nationwide | |
| CLASS II | Papaverine Hydrochloride Injection, USP, 60 mg/ (30 mg/mL) recalledPapaverine Hydrochloride | Vitae Enim Vitae Scientific | Sterility | Nationwide |
More recalls from Vitae Enim Vitae Scientific
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Papaverine Hydrochloride Injection, USP, 60 mg/ (30 mg/mL) recalledPapaverine Hydrochloride | Vitae Enim Vitae Scientific | Sterility | Nationwide |
| Drug | CLASS II | Phenobarbital Sodium Injection, USP, 130 mg/mL recalledPhenobarbital Sodium | Vitae Enim Vitae Scientific | Sterility | Nationwide |
| Drug | CLASS II | Phenobarbital Sodium Injection, USP, 65mg/mL recalledPhenobarbital Sodium | Vitae Enim Vitae Scientific | Sterility | Nationwide |