Drug product
HEPARIN LOCK SODIUM*** (25X1ML) 100U/ML INJECTABLE 50 ML; HEPARIN LOCK SODIUM*** (25X5ML) 100U/ML INJECTABLE 125 MLS; HEPARIN SODIUM (25X30ML)** 1000U/ML(1MU/ML) INJECTABLE 120 ML, 60 ML, 90 ML; HEPARIN SODIUM **25X1ML 1000U/ML(1MU/ML INJECTABLE 25 ML, 50 ML (7 DIFFERENT PRODUCTS)
D-1531-2012
Product summary
- Event
- Event 62416
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12 units
- Official record key
drug-enforcement:D-1531-2012
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: 0387947 0391167 0394583 0394583 0394579 0390379 0390379
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