Franck's Lab Inc., d.b.a. Franck's Compounding Lab recalls DMSO / BUPIVACAINE HCL 50%/0.5% INJECTABLE 100 ML, 50 ML; DMSO 100% INJECTABLE 100 ML; DMSO FORTIFIED IRRIGATION - W/O H
Recalled August 22, 2012 · FDA recall D-1505-2012 · Franck's Lab Inc.,
Hazard
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 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. · FDA Class II
Units
107 units
Sold at
Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and West Indies
Description
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 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Product
DMSO / BUPIVACAINE HCL 50%/0.5% INJECTABLE 100 ML, 50 ML; DMSO 100% INJECTABLE 100 ML; DMSO FORTIFIED IRRIGATION - W/O HEPARIN SOLUTION 350 ML; DMSO FORTIFIED IRRIGATION 50%/0.01%/44%/1% SOLUTION 1000 ML, 1200 ML, 150 ML, 200 ML, 250 ML, 300 ML, 400 ML, 500 ML, 600 ML; DMSO FORTIFIED IRRIGATION 50%/44%/1% SOLUTION 50 ML; DMSO FORTIFIED IRRIGATION W/LIDOCAINE 50%/0.01%/44%/1%/1% SOLUTION 250 ML; DMSO IRRIGATION - NACHO3 50% SOLUTION 100 ML, 300 ML, 400 ML, 500 ML, 600 ML; DMSO W/LIDOCAINE 50%/0.5% SOLUTION 100 ML, 1200 ML, 150 ML, 200 ML, 250 ML, 2500 ML, 30 ML, 300 ML, 400 ML, 50 ML, 500 ML, 600 ML (32 DIFFERENT PRODUCTS)
Manufacturer(s)
Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →