Franck's Lab Inc., d.b.a. Franck's Compounding Lab recalls OXYTOCIN 10UNITS/ML INJECTABLE 25 ML; OXYTOCIN**(25X1ML) 10U/ML INJECTABLE 25 MLS (2 DIFFERENT PRODUCTS)
Recalled August 22, 2012 · FDA recall D-1590-2012 · 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
2 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
OXYTOCIN 10UNITS/ML INJECTABLE 25 ML; OXYTOCIN**(25X1ML) 10U/ML INJECTABLE 25 MLS (2 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 →