FDAFDA · Food and drugs·Recall number D-1624-2012
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)
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: 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
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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