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
Is Tetracaine recalled?
38 FDA recalls mention Tetracaine. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Tetracaine.
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
Class II · Moderate risk Terminated
Profound-PE Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl/Phenylephrine, 10% / 10% / 4% / 2%, Spear-Peppermint…
Reason CGMP Deviations
Class II · Moderate risk Terminated
Profound-PE Dental Gel, Lidocaine HCl/ Prilocaine HCl/ Tetracaine HCl/ Phenylephrin HCl, 10% / 10% / 4% / 2%…
Reason CGMP Deviations
Class II · Moderate risk Terminated
Profound Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl, 10% / 10% / 4%, Spearmint-Peppermint, Multiple Dose Container…
Reason CGMP Deviations
Class II · Moderate risk Terminated
Profound Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl, 10%/10%/4% Raspberry Marshmallow, 30 grams per jar, Multiple…
Reason CGMP Deviations
Class II · Moderate risk Terminated
LET Topical Gel, Lidocaine HCL / Epinepherine / Tetracaine HCl, 4%/0.05%/0.5%, 3 mL per syringe, Single Dose Syringe for Topical…
Reason CGMP Deviations
Class II · Moderate risk Terminated
LT Topical Cream, Lidocaine/Tetracaine, 23%/7%, 60gm per jar, Multiple Dose Container for Topical Use, Edge Pharma, LLC, 856…
Reason CGMP Deviations
Class II · Moderate risk Terminated
BLT Topical Cream, Benzocaine/Lidocaine/Tetracaine, 20%/8%/4%, 60gm per jar, Multiple Dose Container For Topical Use, Edge…
Reason CGMP Deviations
Class II · Moderate risk Terminated
Lidocaine/Tetracaine (LIPO110)* 23%/7% Ointment 100 GMS per 4 ounce plastic ointment jar, Rx Only, Stanley Specialty Pharmacy…
Reason Superpotent Drug. Lidocaine higher concentration than listed
Class II · Moderate risk Terminated
LETS GEL KIT Convenience Pack (To prepare 100 mL LETS GEL), Contains: LETS Powders for Gel: Lidocaine Hydrochloride - 4 g…
Reason Microbial contamination of non-sterile product.
Class II · Moderate risk Completed
OCuSOFT Tetravisc Tetracaine HCl 0.5% Sterile Anesthetic, 5 mL, Mfd. for OCuSOFT, Inc. PO Box 429 Richmond, TX 77406-0429 Made in…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Completed
OCuSOFT Tetravisc Tetracaine HCl 0.5% Sterile Anesthetic Single Dose 0.6 mL, Rx only, Mfd. for OCuSOFT, Inc. PO Box 429 Richmond…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Completed
OCuSOFT Tetravisc Forte Tetracaine HCl 0.5 % Sterile Anesthetic, Rx only, 5 mL, Mfd. For OCuSOFT, Inc. Rosenberg, TX 77471 Mfg…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Completed
OCuSOFT Tetravisc Forte (Tetracaine HCl) 0.5% Sterile Anesthetic, 0.6 mL Single Dose (12/CT), Rx only, OCuSOFT, Inc. PO Box 492…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Completed
Tetcaine (Tetracaine Hydrochloride) Ophthalmic Solution USP, 0. 5 fl oz (15 mL), Rx only, Manufactured for OCuSOFT, Inc…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Completed
Altacaine (Tetracaine Hydrochloride) Ophthalmic Solution, USP, 0.5%, 15 mL, Rx only, Mfd. by: Altaire Pharmaceuticals Inc…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
LET Gel 4% (Lidocaine HCl 4% + EPINEPHrine HCl 0.05% + Tetracaine HCl 0.5%), 3mL Single Use Syringe, Rx only, US Compounding…
Reason Labeling: Incorrect or Missing Lot and/or Exp Date: Labels are missing lot and expiration date and are printed as Lot# YYYDDYY@XX with a Beyond Use…
Class II · Moderate risk Terminated
Benzo/Lido/Tetracaine 20%-8%-8% Topical Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd…
Reason Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Class II · Moderate risk Terminated
Benzocaine 20%, Lidocaine 8%, Tetracaine 4% Topical Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of…
Reason Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Class II · Moderate risk Terminated
Benzocaine 20%, Lidocaine 6%, Tetracaine 4% Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd…
Reason Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Class II · Moderate risk Terminated
LIDOCAINE CREAM in all strengths including: 5%, 8%, 23%, 30%, LIDOCAINE / PRILOCAINE / MELYLEPHRINE 15% / 5% / 0.5% CREAM…
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
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