Class III · Low risk Terminated
LET Gel (Lidocaine HCL/Epinephrine Bitartrate/Tetracaine HCL 4%/0.18%/0.5% Topical Gel), Single-use Topical Syringe, 3mL syringe…
Reason Product Mix-up: Incorrect Product Formulation
Tetracaine(buffered) 0.25% solution, Clinical Specialties Compounding Pharmacy, 318…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
What was recalled
Tetracaine(buffered) 0.25% solution, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
- Recalling firm
- Clinical Specialties Compounding Pharmacy
- Origin
- GA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-679-2013
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
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Class II · Moderate risk Terminated
New & Improved Blue Gel Anesthetic, to reduce pain and swelling during pain sensitive procedures, 1 oz bottle, distributed by…
Reason cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API.
Class II · Moderate risk Terminated
Tetracaine Hydrochloride Ophthalmic Solution, 0.5%, 4 mL bottle, Rx only, MFG: Alcon Surgical Inc., NDC 0065-0741-14
Reason cGMP deviations: Temperature abuse
Class II · Moderate risk Terminated
TETRACAINE 1% Tetracaine HCI Injection, USP, 20mg/2mL (10mg/mL), 10 x 2ml Single Use Vials per box, Rx only, Manufactured for…
Reason Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products…
Class II · Moderate risk Terminated
Tetracaine HCl Nasal Solution, 4%, 240 mL per bottle, Multiple Dose Container for Intranasal Use, Edge Pharma, LLC, 856 Hercules…
Reason CGMP Deviations
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