Drug product
THERACYS, (BCG VACCINE) LIVE W/DILUENT** 81MG INJECTABLE 1 VIAL 1 VIALS 12 VIAL 12 VIALS 2 VIALS 3 VIALS 4 VIAL 4 VIALS 5 VIAL 5 VIALS 6 VIAL 6 VIALS 8 VIALS (13 DIFFERENT PRODUCTS)
D-1624-2012
Product summary
- Event
- Event 62443
- Status
- Terminated
- Classification
- Class II
- Quantity
- 53 units
- Official record key
drug-enforcement:D-1624-2012
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: 0385046 0406983 0367360 0384324 0406983 0397099 0398852 0398855 0398856 0405772 0406983 0390146 0398705 0398707 0398709 0398717 0398721 0398732 0377099 0377104 0384258 0384317 0390142 0390148 0390154 0390160 0390163 0390146 0404961 0369755 0377099 0377101 0377104 0380763 0384258 0384323 0384324 0390142 0390148 0391675 0400729 0405530 0377099 0377101 0377104 0380763
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