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FDAFDA · Food and drugs·Recall number D-1464-2012

BEVACIZUMAB & DXM, SDPF - (0.06ML SYRINGE, 31G, 5/16") 25MG/100MG/ML INJECTABLE 0.72 ML; BEVACIZUMAB & DXM, SDPF - (0.06ML SYRINGE, 31G, 5/16") 25MG/20MG/ML INJECTABLE 3 ML, 4.5 ML; BEVACIZUMAB & DXM, SDPF - (0.075ML SYRINGE, 30G, 1/2") 25MG/20MG/ML INJECTABLE 0.225 ML; BEVACIZUMAB & DXM, SDPF - (0.07ML SYRINGE, 30G, 1/2") 25MG/20MG/ML INJECTABLE 0.07 ML, 1.33 ML, 1.4 ML, 1.47 ML; BEVACIZUMAB & DXM, SDPF - (0.07ML SYRINGE, 30G, 1/2") 25MG/40MG/ML INJECTABLE 0.35 ML, 0.7 ML, 1.05 ML; BEVACIZUMAB & DXM, SDPF - (0.07ML SYRINGE, NO NEEDLE) 25MG/40MG/ML INJECTABLE 0.63 ML; BEVACIZUMAB & DXM, SDPF - (0.09ML SYRINGE, 30G, 1/2") 25MG/20MG/ML INJECTABLE 1.8 ML, 2.7 ML; BEVACIZUMAB & DXM, SDPF - (0.09ML SYRINGE, 31G, 5/16") 25MG/20MG/ML INJECTABLE 0.18 ML, 0.27 ML, 0.45 ML, 1.08 ML, 13.5 ML,2.25 ML, 4.5 ML; BEVACIZUMAB & DXM, SDPF - (0.1ML SYRINGE, 30G, 1/2") 25MG/16MG/ML INJECTABLE 0.3 ML, 0.4 ML, 0.5 ML, 1 ML, 1.2 ML, 1.5 ML, 2 ML, 2.5 ML, 5 ML, 7.5 ML; BEVACIZUMAB & DXM, SDPF - (0.1ML SYRINGE, 30G, 1/2") 25MG/40MG/ML INJECTABLE 4 ML, 6 ML; BEVACIZUMAB & DXM, SDPF - (0.1ML SYRINGE, 31G, 5/16") 25MG/16MG/ML INJECTABLE 2 ML, 2.5 ML; BEVACIZUMAB & DXM, SDPF - (0.1ML SYRINGE, 31G, 5/16") 25MG/20MG/ML INJECTABLE 0.3 ML, 0.4 ML, 0.5 ML, 0.6 ML, 0.7 ML, 0.8 ML, 1 ML, 1.5 ML, 55.1 ML, 57.5 ML, 57.6 ML, 58 ML, 7.5 ML; BEVACIZUMAB & DXM, STSL (0.1ML SYRINGE, 30G, 1/2") 25MG/16MG/ML INJECTABLE 0.3 ML; BEVACIZUMAB & TMC, SDPF - (0.075ML SYRINGE, 30G 1/2") 25MG/40MG/ML INJECTABLE 0.075 ML, 0.15 ML, 0.225 ML, 0.375 ML, 0.75 ML, 1.125 ML, 1.5 ML; BEVACIZUMAB & TMC, SDPF (0.075ML SYRINGE, 30G, 1/2") 25MG/80MG/ML INJECTABLE 0.45 ML, 0.75 ML; BEVACIZUMAB & TMC, SDPF - (0.1ML SYRINGE, 30G, 1/2") 25MG/40MG/ML INJECTABLE 0.3 ML, 0.5 ML, 1 ML, 2 ML, 2.5 ML, 3 ML; BEVACIZUMAB & TMC, SDPF - (0.1ML SYRINGE, NO NEEDLE) 25MG/40MG/ML INJECTABLE 0.5 ML; BEVACIZUMAB & TMC, SDPF W/ STSL - (0.075ML SYRINGE, 30G, 1/2") 25MG/80MG/ML INJE 0.375 ML, 0.525 ML, 0.75 ML, 1.125 ML; BEVACIZUMAB & TMC, SDPF W/ STSL - (0.15ML SYRINGE, 30G, 1/2") 25MG/40MG/ML INJEC 0.6 ML, 0.75 ML, 0.9 ML, 1.05 ML; BEVACIZUMAB & TMC, SDPF W/ STSL - (0.1ML SYRINGE, 30G, 1/2") 25MG/20MG/ML INJECT 0.2 ML, 0.4 ML; BEVACIZUMAB & TMC, SDPF W/ STSL - (0.1ML SYRINGE, 30G, 1/2") 25MG/40MG/ML INJECT 0.6 ML, 1 ML; BEVACIZUMAB IN ARTIFICIAL TEARS 0.5% (5MG/ML) OPHTHALMIC 5 ML; BEVACIZUMAB, SDPF - (0.05ML SYRINGE, 27G, 1/2") 25MG/ML INJECTABLE 0.3 ML; BEVACIZUMAB, SDPF - (0.05ML SYRINGE, 30G, 1/2") 25MG/ML INJECTABLE 0 MLS, 0.05 ML, 0.1 ML, 0.15 ML, 0.2 ML, 0.2 MLS, 0.25 ML, 0.25 MLS, 0.3 ML, 0.3 MLS, 0.35 ML, 0.36 ML, 0.4 ML, 0.45 ML, 0.5 ML, 0.6 ML, 0.65 ML, 0.7 ML, 0.75 ML, 0.8 ML, 1 ML, 1.2 ML, 1.25 ML, 1.5 ML,1.5 MLS, 1.75 ML, 1.8 ML, 10 ML, 15 ML, 2 ML, 2.25 ML, 2.5 ML, 2.5 MLS, 2.55 ML, 2.6 ML, 3 ML, 3.1 ML, 3.5 ML, 3.6 ML, 3.65 ML, 3.7 ML, 3.75 ML, 3.96 MLS, 4 ML, 4.5 ML, 5 ML, 5 MLS, 7 ML, 7.2 ML, 7.2 MLS, 7.25 ML, 7.3 MLS, 7.3 VIAL, 7.4 MLS, 7.5 ML; BEVACIZUMAB, SDPF - (0.05ML SYRINGE, 31G, 5/16") 25MG/ML INJECTABLE 0.1 ML, 0.15 ML, 0.2 ML, 0.25 ML, 0.3 ML, 0.35 ML, 0.4 ML, 0.5 ML, 0.55 ML, 0.6 ML, 0.65 ML, 0.7 ML, 0.75 ML, 0.8 ML, 0.85 ML, 0.9 ML, 1 ML, 1.1 ML, 1.2 ML, 1.25 ML, 1.5 ML, 1.75 ML, 10 ML, 12.25 ML, 12.5 ML, 13.5 ML, 15 ML, 17.5 ML, 2 ML, 2.25 ML, 2.5 ML, 2.6 ML, 3 ML, 3.5 ML, 3.75 ML, 4 ML, 4.5 ML, 5 ML, 5.05 ML, 6 ML, 6.25 ML, 6.35 ML, 7.5 ML, 8.75 ML; BEVACIZUMAB, SDPF - (0.06ML SYRINGE, 30G, 1/2") 25MG/ML INJECTABLE 1.2 ML, 2.88 ML; BEVACIZUMAB, SDPF - (0.06ML SYRINGE, 31G, 5/16") 25MG/ML INJECTABLE 1.5 ML, 1.8 ML, 2.4 ML, 3 ML, 3.6 ML, 4.8 ML, 6 ML; BEVACIZUMAB, SDPF - (0.07ML SYRINGE, 30G, 1/2") 25MG/ML INJECTABLE 1.75 ML; BEVACIZUMAB, SDPF - (0.07ML SYRINGE, 31G, 5/16") 25MG/ML INJECTABLE 0.14 ML, 0.21 ML, 1.75 ML, 3.5 ML, 4.2 ML, 5.6 ML, 7 ML; BEVACIZUMAB, SDPF - (0.08ML SYRINGE, 30G, 1/2") 25MG/ML INJECTABLE 0.08 ML; BEVACIZUMAB, SDPF - (0.08ML SYRINGE, NO NEEDLE) 25MG/ML INJECTABLE 0.08 ML, 0.16 ML, 0.24 ML, 0.32 ML, 0.48 ML, 16 ML, 8 ML; BEVACIZUMAB, SDPF - (0.1

Published August 22, 2012 · Recall initiated: May 25, 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 because 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, and West Indies
Lot
Rx #'s: 0359160 0405079 0364389 0364389 0361241 0377683 0377683 0377683 0377683 0401661 0401661 0401661 0390308 0359300 0404762 0382630 0407996 0361441 0407996 0387326 0398781 0356812 0398781 0356812 0375792 0403341 0375792 0399708 0387144 0399708 0387144 0375792 0353919 0375792 0389701 0357461 0387144 0389701 0397437 0352503 0357461 0377580 0377580 0386958 0386958 0367201 0371279 0371279 0367201 0384322 0371279 0384322 0367201 0384322 0384322 0375486 0375486 0375486 0375486 0390996 0381779 0361290 0391677 0403321 0361290 0403321 0397396 0393484 0401740 0390929 0393759 0384195 0388799 0388805 0393759 0388805 0393484 0387836 0387836 0398119 0350119 0359128 0400639 0353914 0394457 0353914 0382205 0353914 0394457 0382205 0393293 0393299 0393300 0399578 0399598 0390926 0393485 0388801 0393485 0388806 0368969 0368969 0390918 0390918 0390918 0392167 0357998 0402352 0393760 0393760 0356752 0401186 0369338 0380167 0367010 0369225 0384207 0385361 0387698 0394363 0395273 0396614 0398024 0398662 0399938 0403502 0408817 0359129 0367010 0367401 0370758 0370759 0370763 0370767 0370768 0370770 0370778 0370779 0370783 0370785 0374018 0374024 0374028 0374036 0379772 0379773 0379774 0387698 0388817 0396342 0407944 0407945 0407946 0408269 0408741 0408742 0408817 0370141 0370142 0371173 0371773 0373627 0376439 0378889 0378890 0378892 0378894 0378897 0378898 0378899 0382662 0382666 0382667 0382669 0382670 0382674 0382919 0383307 0383314 0383346 0385937 0388305 0396302 0399567 0401360 0407944 0407945 0407946 0407948 0407951 0407955 0408233 0408237 0408242 0408248 0408250 0408251 0408259 0408262 0408264 0408265 0408271 0408272 0408274 0408280 0408281 0408284 0408672 0408673 0408674 0408675 0408676 0408677 0408678 0408679 0408680 0408681 0408682 0408683 0408684 0408685 0409171 0409173 0409188 0409191 0409205 0409207 0409825 0409826 0409827 0409828 0409829 0409830 0409831 0352123 0359738 0376439 0384103 0385937 0388817 0401360 0401986 0367896 0355412 0359738 0360220 0371173 0372305 0372673 0375789 0378673 0388774 0391407 0392221 0396687 0400615 0404394 0409879 0409880 0367896 0354585 0372673 0375616 0376439 0377592 0380869 0388817 0389473 0390204 0391693 0392559 0396781 0397261 0397948 0398535 0399761 0401997 0367896 0349959 0350509 0365293 0367347 0369312 0371910 0372413 0373066 0373071 0375917 0375918 0376390 0378853 0385894 0387469 0387471 0387472 0388125 0388126 0388128 0388133 0388136 0388635 0389211 0389215 0390369 0390839 0390843 0390848 0391153 0391338 0391340 0391763 0391764 0391861 0391864 0392979 0393223 0394391 0394393 0394501 0394502 0394707 0395314 0395316 0396363 0396818 0396827 0396829 0397889 0397893 0398006 0398551 0398553 0399238 0399240 0399488 0399489 0399502 0399891 0399892 0399893 0399894 0401526 0401528 0402863 0403606 0403
Risk classification
Class II
Area (FDA)
drug
Country
United States

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