Franck's Lab Inc., d.b.a. Franck's Compounding Lab recalls TESTOSTERONE CYP/ESTRADIOL CYP 50MG/2MG/ML INJECTABLE 5 ML; TESTOSTERONE CYPIONATE 50MG/ML INJECTABLE 12 ML 2.5 ML (
Recalled August 22, 2012 · FDA recall D-1621-2012 · 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. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. · FDA Class II
Units
17 units
Sold at
Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, 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. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Product
TESTOSTERONE CYP/ESTRADIOL CYP 50MG/2MG/ML INJECTABLE 5 ML; TESTOSTERONE CYPIONATE 50MG/ML INJECTABLE 12 ML 2.5 ML (4 DIFFERENT PRODUCTS) 5 ML; TESTOSTERONE PROPIONATE 200MG/ML INJECTABLE 10 ML
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 →