Class III · Low risk Terminated
LET Gel
Reason Product Mix-up: Incorrect Product Formulation
Tetracaine HCl Nasal Solution
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations
What was recalled
Tetracaine HCl Nasal Solution, 4%, 240 mL per bottle, Multiple Dose Container for Intranasal Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, 05446, NDC 05446-1195-03, packaged in bottles.
- Recalling firm
- Edge Pharma, LLC
- NDC code
- 05446-1195-03
- Origin
- VT, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0447-2022
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Tetracaine recalls
See all
Class II · Moderate risk Terminated
New & Improved Blue Gel Anesthetic
Reason cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API.
Class II · Moderate risk Terminated
Tetracaine Hydrochloride Ophthalmic Solution
Reason cGMP deviations: Temperature abuse
Class II · Moderate risk Terminated
TETRACAINE 1% Tetracaine HCI Injection
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.
Class II · Moderate risk Terminated
Profound-PE Dental Gel
Reason CGMP Deviations
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