Drug Enforcement D-1519-2012

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.

Status

Terminated

Classification

Class II

Report Date

August 22, 2012

Termination Date

August 13, 2014

Product Information

Product description
FLUORESCEIN/INDOCYANINE, LYOPHILIZED 200MG/10MG VIAL INJECTABLE 12 VIAL, 20 VIAL, 24 VIAL; FLUORESCEIN/INDOCYANINE, LYOPHILIZED 200MG/15MG VIAL INJECTABLE 23 VIAL, 25 VIAL, 30 VIAL, 7 VIAL; FLUORESCEIN/INDOCYANINE, LYOPHILIZED 200MG/5MG VIAL INJECTABLE 1 VIAL, 10 VIAL, 12 VIAL, 13 VIAL, 15 VIAL, 2 VIAL, 20 VIAL, 24 VIAL, 3 VIAL, 30 VIAL, 40 VIAL, 41 VIAL, 5 VIAL, 50 VIAL, 6 VIAL, 7 VIAL, 9 VIAL; FLUORESCEIN/INDOCYANINE, LYOPHILIZED 300MG/5MG VIAL INJECTABLE 10 VIAL, 15 VIAL, 20 VIAL; FLUORESCEIN/INDOCYANINE, LYOPHILIZED 300MG/7.5MG VIAL INJECTABLE 20 vials, 6 VIAL; FLUORESCEIN/INDOCYANINE, LYOPHILIZED 400MG/15MG VIAL INJECTABLE 10 VIAL, 14 VIAL, 15 VIAL, 16 VIAL, 2 VIAL, 20 VIAL, 21 VIAL, 25 VIAL, 250 VIAL, 3 VIAL, 30 VIAL, 32 VIAL, 4 VIAL, 40 VIAL, 5 VIAL, 50 VIAL, 6 VIAL, 8 VIALS, 9 VIAL; FLUORESCEIN/INDOCYANINE, LYOPHILIZED 500MG/25MG VIAL INJECTABLE 1 VIAL, 12 VIAL, 2 VIAL, 23 VIAL, 30 VIAL, 6 VIAL, 8 VIAL; FLUORESCEIN/INDOCYANINE, LYOPHILIZED 600MG/12.5MG VIAL INJECTABLE 58 VIAL, 680 VIAL, 692 VIAL, 724 VIAL, 750 VIAL; FLUORESCEIN/INDOCYANINE, LYOPHILIZED 600MG/15MG VIAL INJECTABLE 2 VIAL, 3 VIAL; FLUORESCEIN/INDOCYANINE, LYOPHYLIZED 1000MG/10MG INJECTABLE 100 VIAL, 137 VIAL, 140 VIAL, 153 VIAL, 200 VIAL, 47 VIAL, 60 VIAL, 63 VIAL (70 DIFFEENT PRODUCTS)
Product quantity
202 units
Reason for recall
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.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and West Indies

Location & Firm

Recalling firm
Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Address
1210 SW 33rd Avenue

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-1519-2012
Event ID
62416
Recall initiation date
May 25, 2012
Center classification date
August 10, 2012
Code info
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
More code info
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