Drug product
CYCLOPENT/FLURBIPR/PHENYLEPH/PROPARACAINE .25%/0.0075%/0.625%/0.125% OPHTHALMIC 56 ML, 70 ML (2 DIFFERENT PRODUCTS)
D-1489-2012
Product summary
- Event
- Event 62416
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6 units
- Official record key
drug-enforcement:D-1489-2012
Official wording
Reason: 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.
Code information: Rx #'s: 0368702 0368702
Distribution pattern: Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and West Indies
Derived failure modes
-
Microbial contamination
fungal growth
-
Sterility assurance
Lack of Assurance of Sterility