Franck's Lab Inc., d.b.a. Franck's Compounding Lab recalls ULTRA-TEST 200 (CYP 80%/PROP 20%) 200MG/ML INJECTABLE 1 ML
Recalled August 22, 2012 · FDA recall D-1636-2012 · 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
1193 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
ULTRA-TEST 200 (CYP 80%/PROP 20%) 200MG/ML INJECTABLE 1 ML 10 ML 10 MLS 12 ML 15 ML 18 ML 2 ML 20 ML 20 MLS 24 ML 3 ML 30 ML 5 ML 6 ML 8 ML 9 ML; ULTRA-TEST 200 IN SESAME OIL (CYP 80%/PROP 20%) 200MG/ML INJECTABLE 10 ML 30 ML 8 ML; ULTRA-TEST 250 (CYP 80%/PROP 20%) 250MG/ML INJECTABLE 10 ML 20 ML (21 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 →