FDAFDA · Food and drugs·Recall number D-1622-2012
TETRACAINE HCL OPHTHALMIC 0.05% SOLUTION 3 ML 6 ML; TETRACAINE HCL P.F. OPHTHALMIC 0.5% SOLUTION 30 ML (3 DIFFERENT PRODUCTS)
Published August 22, 2012 · Recall initiated: May 21, 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. 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, West Indies
- Lot
- Rx #'s: 0387030 0388227 0388955 0389127 0389637 0389994 0391604 0391610 0394004 0394519 0394522 0396467 0396470 0397420 0397616 0399672 0400482 0401216 0401503 0402138 0403400 0403543 0404150 0405978 0362094 0382304
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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