FDAFDA · Food and drugs·Recall number D-1601-2012
PHENYLEPHRINE/TROPICAMIDE/PROPARACAINE SOLUTION 2.5%/1%/0.5% OPHTHALMIC 120 ML 25 ML 30 ML 5 ML 90 ML (5 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: 0392909 0392909 0392909 0387234 0392909
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States