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Class II · Moderate risk Terminated Initiated May 21, 2012 (14 years ago)

Lidocaine HCL

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.

Cause type: Sterility / contamination

A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.

What was recalled

LIDOCAINE HCL (STERILE) 4% JELLY 120 ML 30 ML; LIDOCAINE HCL 4% SOLUTION 200 ML 300 ML 500 ML 600 ML; LIDOCAINE HCL 1% INJECTABLE 100 ML 1000 ML 1200 ML 1250 ML 150 ML 1500 ML 180 ML 20 ML 200 ML 2000 ML 240 ML 250 ML 2500 ML 300 ML 350 ML 360 ML 400 ML 480 ML 50 ML 500 ML 60 ML 600 ML 720 ML 750 ML 7500 ML 90 ML; LIDOCAINE HCL 10% INJECTABLE 1000 ML; LIDOCAINE HCL IN BSS - P.F. OPHTHALMIC 1% INJECTABLE 30 ML; LIDOCAINE HCL W/EPI (25X30ML) MDV *** 1%-1:100000 INJECTABLE 150 MLS 180 MLS 50 VIALS; LIDOCAINE HCL, AQUEOUS 2% INJECTABLE 100 ML 1000 ML 120 ML 1200 GM 1200 ML 150 ML 1500 ML 20 ML 200 ML 2000 ML 240 ML 250 ML 2500 ML 300 ML 40 ML 450 ML 480 ML 50 ML 500 ML 600 ML 80 ML; LIDOCAINE HCL, AQUEOUS PF 2% INJECTABLE 1200 ML 1500 ML 1600 ML 200 ML 250 ML 50 ML 500 ML 600 ML 900 ML; LIDOCAINE HCL, AQUEOUS, BUFFERED, P.F. 2% INJECTABLE 1000 ML 500 ML; LIDOCAINE HCL, P.F. 0.5% INJECTABLE 1000 ML; LIDOCAINE HCL, P.F. 1% INJECTABLE 100 ML 12 ML 120 ML 125 ML 150 ML 24 ML 240 ML 2500 ML 2670 ML 30 ML 300 ML 40 ML 48 ML 50 ML 6 ML 60 ML 720 ML 80 ML 900 ML; LIDOCAINE HCL, P.F. 4% INJECTABLE 100 ML 1000 ML 125 ML 225 ML 240 ML 75 ML LIDOCAINE HCL/METHYLCELLULOSE 1%/2% JELLY 2 ML; LIDOCAINE HCL/METHYLCELLULOSE 2%/2% JELLY 1000 ML 1000 MLS 12000 ML 200 ML 2000 ML 2000 MLS 3000 ML 4000 ML 500 ML 5000 ML 6000 ML 750 ML; LIDOCAINE HCL/METHYLCELLULOSE 4%/2% JELLY 1000 ML; LIDOCAINE HCL/METHYLCELLULOSE 5%/2% JELLY 1000 ML; LIDOCAINE HCL/METHYLCELLULOSE 8%/2% JELLY 1000 ML (111 DIFFERENT PRODUCTS)

Drug: Lidocaine Category: Eye Drops & Ophthalmic

Recalling firm
Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Origin
FL, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1558-2012 · FDA notice

Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.

Other Lidocaine recalls

See all
Class II · Moderate risk

Lidocaine Ointment USP

Failed Content Uniformity Specifications. Out of Specification for Assay during analysis at the 24- month long term stability station, at (25¿C,60%RH).

Ongoing Wrong potency / content Sun Pharma /Taro D-0848-2026
Class III · Low risk

Lidolog Kit

Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan

Ongoing Labeling / mix-up Asclemed USA Inc. D-0713-2026

Other recalls by Franck's Lab Inc., d.b.a. Franck's Compounding Lab

All 2012 recalls
Class II · Moderate risk

Ceftriaxone 1 gm/50 mL D5W

Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.

Ongoing Sterility / contamination Franck's Lab Inc dba Trinity Care Solutions D-1482-2014
Class II · Moderate risk

Cefepime 2 gm/100 mL 0.9%NS

Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.

Ongoing Sterility / contamination Franck's Lab Inc dba Trinity Care Solutions D-1481-2014
Class II · Moderate risk

Ceftriaxone 2 gm/100 mL D5W

Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.

Ongoing Sterility / contamination Franck's Lab Inc dba Trinity Care Solutions D-1480-2014
Class II · Moderate risk

Cefepime 1 gm/100 mL 0.9%NS

Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.

Ongoing Sterility / contamination Franck's Lab Inc dba Trinity Care Solutions D-1479-2014