Fluorescein/indocyanine recall: Sterility Concern
FLUORESCEIN/INDOCYANINE, LYOPHILIZED 200MG/10MG VIAL INJECTABLE 12 VIAL, 20 VIAL, 24 VIAL; FLUORESCEIN/INDOCYANINE, LYOPHILIZED 200MG/15MG VIAL…
Why was Fluorescein/indocyanine 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 because 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: 0387858 0387858 0387858 0360970 0360970 0360970 0360970 0394556 0394868 0388495 0389506 0401222 0406557 0393109 0390858 0406557 0394195 0384679 0390858 0401222 0386372 0393109 0387476 0387651 0394195 0396927 0400464 0384679 0389105 0389105 0389105 0387476 0384679 0388495 0389105 0387476 0392323 0393109 0394195 0390858 0389105 0391704 0391704 0391704 0365030 0392325 0359065 0364511 0365182 0366253 0366265 0370058 0384847 0387893 0387894 0388887 0392782 0393234 0393654 0395364 0400787 0401230 0408490 0394164 0350907 0354075 0364511 0370058 0384847 0387894 0388887 0392782 0393234 0394910 0395364 0410310 0394449 0388820 0354075 0364600 0370665 0393234 0393654 0394164 0395364 0400787 0370665 0349864 0384847 0403576 0370058 0366253 0388820 0370058 0370058 0373554 0370665 0393234 0359065 0366368 0373554 0384847 0387893 0387894 0388887 0393915 0394164 0390169 0394074 0394164 0400289 0389633 0394449 0394557 0388093 0382934 0379184 0379184 0388093 0394557 0388093 0390228 0390228 0390228 0390228 0390228 0403847 0403851 0387650 0396924 0358285 0376244 0397588 0404422 0404430 0376244 0376244 0376244 0376244 0376244 0376244 0376244
- Product
- FLUORESCEIN/INDOCYANINE, LYOPHILIZED 200MG/10MG VIAL INJECTABLE 12 VIAL, 20 VIAL, 24 VIAL; FLUORESCEIN/INDOCYANINE, LYOPHILIZED 200MG/15MG VIAL…
- Recalling firm
- Franck's Lab Inc., d.b.a. Franck's Compounding Lab
- Quantity
- 202 units
- Distribution
- Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and West Indies
- Recall date
- August 22, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)