Drug product
KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE 10 ML 24 ML 500 ML; KETOROLAC TROMETHAMINE 60MG/ML INJECTABLE 48 ML; KETOROLAC TROMETHAMINE, 1ML SDV**25X1ML 30MG/ML INJECTABLE 50 ML 75 ML; KETOROLAC TROMETHAMINE, P.F. 60MG/ML INJECTABLE 10 ML (7 DIFFERENT PRODUCTS)
D-1552-2012
Product summary
- Event
- Event 62443
- Status
- Terminated
- Classification
- Class II
- Quantity
- 14 units
- Official record key
drug-enforcement:D-1552-2012
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. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Code information: Rx #'s: 0407225 0407852 0405175 0408193 0403243 0404737 0392573 0392575 0392577 0392575 0401951 0404831
Distribution pattern: Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies
Derived failure modes
-
Microbial contamination
fungal growth
-
Sterility assurance
Lack of Assurance of Sterility