FDA-Drug2012-08-22Class II
PYRIDOXINE 100MG/ML INJECTABLE 150 ML 180 ML 300 ML 360 ML 450 ML (5 DIFFERENT PRODUCTS)
Franck's Lab Inc., d.b.a. Franck's Compounding Lab
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.
Sold states
Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies
Affected count
10 units
Manufactured in
1210 SW 33rd Avenue, Ocala, FL, United States
Products
PYRIDOXINE 100MG/ML INJECTABLE 150 ML 180 ML 300 ML 360 ML 450 ML (5 DIFFERENT PRODUCTS)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1609-2012Don't want to check this manually?
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