Class III · Low risk Terminated
LET Gel
Reason Product Mix-up: Incorrect Product Formulation
OCuSOFT Tetravisc Tetracaine HCl 0.5% Sterile Anesthetic Single Dose 0.6 mL
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility
What was recalled
OCuSOFT Tetravisc Tetracaine HCl 0.5% Sterile Anesthetic Single Dose 0.6 mL, Rx only, Mfd. for OCuSOFT, Inc. PO Box 429 Richmond, TX 77406-0429 800-233-5469 Made in USA, Mfd. by: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 54799-505-01
- Recalling firm
- Altaire Pharmaceuticals, Inc.
- NDC code
- 54799-505-01
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0445-2020
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
Tetracaine HCl Nasal Solution
Reason CGMP Deviations
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