FDAFDA · Food and drugs·Recall number D-1463-2012
BACTERIOSTATIC SODIUM CHLORIDE 10ML VIAL** 0.9% INJECTABLE 10 ML, 10 MLS, 100 ML, 120, 20 MLS, 200 ML, 30 MLS, 40 ML, 50 ML, 50 MLS (10 DIFFERENT PRODUCTS)
Published August 22, 2012 · Recall initiated: May 25, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Franck's Lab Inc., d.b.a. Franck's Compounding Lab
- Distributor
- Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and West Indies
- Lot
- Rx #'s: 0404160, 0404162, 0404697, 0405589, 0407510, 0407568, 0407772, 0409510, 0409877, 0410186, 0404478, 0405838, 0406815, 0406819, 0405467, 0407857, 0404470, 0404712, 0406839, 0406523, 0407706, 0405838, 0405842, 0406839
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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