Is Prilocaine recalled?

13 FDA recalls mention Prilocaine. The most recent are listed below.

Recalls are matched by product description. A recall usually affects specific lots, not every package of Prilocaine.

Class II · Moderate risk Ongoing Apr 26, 2023

Lidocaine 2.5% & Prilocaine 2.5% Cream, 30 gram tubes, Rx Only, Manufactured by: HI-TECH PHARMACAL CO., INC., Amityville, NY…

Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Akorn, Inc. D-0821-2023

Class II · Moderate risk Ongoing Apr 21, 2022

Lidocaine Prilocaine Cream USP, 2.5%/2.5% Net Wt. 30 gram tube, Rx Only, Distributed by: McKesson Corporation dba Sky Packaging…

Reason CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability…

McKesson Corporation dba McKesson Drug Company NDC 63739-054-66 D-0849-2022

Class II · Moderate risk Terminated Apr 15, 2022

Lidocaine 2.5% and Prilocaine 2.5% Cream, USP, packaged in a) 5 g tubes (NDC 0591-2070-72), b) 30 g tubes (NDC 0591-2070-30), Rx…

Reason cGMP Deviations

Teva Pharmaceuticals USA Inc NDC 0591-2070-72 D-0794-2022

Class II · Moderate risk Terminated Apr 13, 2022

Lidocaine and Prilocaine Cream, 2.5%/2.5%, 5 gram tubes, Rx only, MFG: Sandoz Pharma, NDC 0168-0357-56

Reason cGMP deviations: Temperature abuse

Mckesson Medical-Surgical Inc. Corporate Office NDC 0168-0357-56 D-1047-2022

Class II · Moderate risk Terminated Dec 6, 2021

Profound-PE Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl/Phenylephrine, 10% / 10% / 4% / 2%, Spear-Peppermint…

Reason CGMP Deviations

Edge Pharma, LLC NDC 05446-0408-10 D-0442-2022

Class II · Moderate risk Terminated Dec 6, 2021

Profound-PE Dental Gel, Lidocaine HCl/ Prilocaine HCl/ Tetracaine HCl/ Phenylephrin HCl, 10% / 10% / 4% / 2%…

Reason CGMP Deviations

Edge Pharma, LLC NDC 05446-1018-10 D-0441-2022

Class II · Moderate risk Terminated Dec 6, 2021

Profound Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl, 10% / 10% / 4%, Spearmint-Peppermint, Multiple Dose Container…

Reason CGMP Deviations

Edge Pharma, LLC NDC 05446-0407-10 D-0440-2022

Class II · Moderate risk Terminated Dec 6, 2021

Profound Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl, 10%/10%/4% Raspberry Marshmallow, 30 grams per jar, Multiple…

Reason CGMP Deviations

Edge Pharma, LLC NDC 05446-0790-10 D-0439-2022

Class II · Moderate risk Terminated Aug 1, 2018

Lidocaine 2.5% and Prilocaine Cream, 2.5%. 30g tube, Rx only, Manufactured by: Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701…

Reason Failed Impurities/Degredation Specifications: Out of Specification results for an unknown impurity was found during routine stability testing at 12…

Akorn, Inc. NDC 50383-667-30 D-1046-2018

Class II · Moderate risk Terminated Feb 9, 2018

Prilocaine HCl USP for prescription compounding, packaged in a) 100g (NDC 58597-8028-6); b) 500g (NDC 58597-8028-7); c) 1000g…

Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure…

American Pharmaceutical Ingredients LLC NDC 58597-8028-6 D-0517-2018

Class II · Moderate risk Terminated Feb 10, 2017

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.

Synergy Rx D-0593-2017

Class II · Moderate risk Terminated Feb 10, 2017

LP CREAM (Lidocaine 15%/Prilocaine 5%), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676

Reason Lack of Assurance of Sterility: There are also CGMP Deviations.

Synergy Rx D-0562-2017

Class II · Moderate risk Terminated Nov 14, 2014

Prilocaine HCl active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184…

Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they…

Attix Pharmaceuticals D-861-2015

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