Theracys recall: Sterility Concern
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…
Why was Theracys recalled?
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 should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- 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…
- Recalling firm
- Franck's Lab Inc., d.b.a. Franck's Compounding Lab
- Quantity
- 53 units
- Distribution
- Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies
- Recall date
- August 22, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)