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U.S. Department of Health and Human Services

Enforcement Report - Week of August 22, 2012

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Product Detail

Product Description 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 - (0.12ML SYRINGE, 30G, 1/2") 25MG/ML INJECTABLE 1.08 ML, 1.2 ML, 1.8 ML, 3.6 ML; BEVACIZUMAB, SDPF - (0.12ML SYRINGE, NO NEEDLE) 25MG/ML INJECTABLE 12 ML, 18 ML, 19.2 ML, 20.4 ML, 22.2 ML, 24 ML, 6 ML, 9 ML, 9.6 ML; BEVACIZUMAB, SDPF - (0.16ML SYRINGE, 30G, 1/2") 25MG/ML INJECTABLE 3.2 ML, 4.8 ML; BEVACIZUMAB, SDPF - (0.1ML SYRINGE, 27G, 1/2") 25MG/ML INJECTABLE 2.5 ML, 3 ML, 3.5 ML, 4 ML, 5 ML, 5.5 ML; BEVACIZUMAB, SDPF - (0.1ML SYRINGE, 30G, 1/2") 25MG/ML INJECTABLE 0.1 ML, 0.2 ML, 0.3 ML, 1 ML, 2 ML, 3 ML, 4 ML; BEVACIZUMAB, SDPF - (0.1ML SYRINGE, 31G 5/16") 25MG/ML INJECTABLE 0.1 ML, 0.6 ML, 1 ML; BEVACIZUMAB, SDPF - (0.1ML SYRINGE, NO NEEDLE) 25MG/ML INJECTABLE 0.5 ML, 2 ML, 3 ML; BEVACIZUMAB, STSL - (0.05ML SYRINGE, 30G, 1/2") 25MG/ML INJECTABLE 0.05 ML, 0.25 ML, 0.5 ML, 0.6 ML, 0.8 ML, 0.95 ML,1 ML, 1.05 ML, 1.2 ML, 1.25 ML, 1.5 ML, 1.8 ML, 1.9 ML, 10 ML, 2 ML, 2.05 ML, 2.25 ML, 3 ML, 3.5 ML, 4 ML, 5 ML; BEVACIZUMAB, STSL - (0.05ML SYRINGE, 30G, 3/8") 25MG/ML INJECTABLE 1 ML, 1.05 ML, 1.5 ML; BEVACIZUMAB, STSL - (0.05ML SYRINGE, 31G, 5/16") 25MG/ML INJECTABLE 0.05 ML, 0.1 ML, 0.15 ML, 0.5 ML, 0.6 ML, 0.75 ML, 1 ML, 1.05 ML, 1.2 ML, 1.25 ML, 1.5 ML, 2 ML, 2.5 ML, 2.75 ML, 3 ML, 3.15 ML, 3.75 ML, 5 ML, 5.5 ML, 6.5 ML, 7.5 ML; BEVACIZUMAB, STSL - (0.1ML SYRINGE, NO NEEDLE) 25MG/ML INJECTABLE 1.2 ML, 1.5 ML, 1.8 ML, 2.1 ML, 2.4 ML (297 DIFFERENT PRODUCTS)
Recall Number D-1464-2012
Classification Class II
Code Info 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 0403609 0403611 0403785 0404539 0404540 0405532 0405933 0406247 0375916 0366046 0366486 0378138 0380869 0386460 0388817 0394444 0398535 0401997 0409796 0378138 0398535 0354936 0355412 0359129 0359985 0360220 0363258 0365502 0367016 0367501 0368624 0371173 0372081 0373976 0375616 0377592 0378673 0382974 0383654 0386404 0387739 0388288 0388774 0388785 0389473 0389828 0392521 0392818 0394444 0398535 0402803 0403654 0404459 0405383 0408232 0409453 0350698 0355237 0366486 0368624 0371173 0378138 0384670 0385775 0388288 0391887 0393789 0396687 0388817 0366486 0356702 0359129 0360220 0367016 0375789 0378673 0382974 0384849 0386404 0387740 0388288 0389473 0390219 0397948 0398337 0398805 0354554 0359129 0388817 0352916 0352996 0354554 0359129 0359985 0361041 0362197 0363258 0365502 0366486 0367016 0367240 0368282 0368624 0371184 0375789 0378583 0378823 0379513 0380679 0382974 0383438 0384676 0384849 0386729 0387024 0387168 0387740 0388154 0388785 0389511 0391887 0392445 0393797 0399912 0400472 0400522 0401225 0405018 0409004 0409245 0379513 0385775 0352372 0361666 0365188 0365502 0366619 0368282 0378583 0378911 0382974 0385549 0387024 0387374 0387420 0389828 0392938 0394683 0397164 0405238 0408232 0349177 0350459 0352916 0354764 0358804 0359985 0363966 0368493 0371184 0378583 0380167 0385014 0385036 0385549 0387024 0387168 0387334 0387374 0387739 0388080 0388154 0388288 0388561 0389828 0390176 0390219 0391013 0392187 0392445 0393559 0394572 0398217 0401225 0402280 0403944 0405665 0407685 0409157 0380167 0354764 0378583 0387024 0387374 0398602 0379513 0390966 0382620 0390262 0390262 0350302 0357190 0360145 0366591 0378823 0380999 0383438 0384207 0384676 0384713 0385014 0385036 0387024 0387739 0388561 0391007 0391265 0391768 0398602 0407622 0409004 0376772 0406033 0351645 0353827 0355623 0360220 0360607 0361078 0361666 0363966 0366600 0366619 0368316 0378911 0380061 0380658 0384676 0384713 0384923 0387739 0390060 0390223 0390262 0392818 0395368 0397164 0398337 0399928 0402827 0405238 0408166 0408815 0380323 0387420 0380061 0353827 0355819 0357190 0361868 0366591 0373924 0378823 0380999 0383438 0387168 0392868 0395368 0399063 0400380 0405406 0408666 0409004 0361868 0353827 0365737 0365737 0389735 0365737 0365737 0380167 0361666 0387815 0380167 0357190 0373924 0380999 0388167 0387488 0352821 0352950 0354664 0365296 0366374 0373924 0380658 0384676 0384923 0385412 0386588 0388167 0390060 0390223 0390262 0394454 0394514 0396082 0399081 0380323 0364967 0399540 0402861 0373924 0380167 0380167 0380167 0380167 0380167 0365296 0386588 0408941 0391001 0396063 0396064 0396069 0396072 0396074 0396076 0406966 0367119 0367128 0367144 0367162 0367167 0367168 0368589 0368907 0370072 0370538 0371351 0373487 0376100 0376101 0376102 0376108 0377388 0377390 0377391 0377639 0378635 0378637 0384407 0400209 0408467 0408474 0408482 0408922 0408924 0408926 0408945 0408955 0408957 0408958 0408959 0408960 0408963 0408965 0408968 0408969 0408971 0408973 0408975 0408976 0408979 0408981 0408982 0408985 0408986 0408988 0409360 0409362 0409363 0409365 0409367 0409368 0409370 0409371 0409455 0409456 0409460 0409462 0409466 0409467 0409469 0409470 0409473 0409474 0409475 0409476 0409478 0409479 0409480 0409481 0409482 0409483 0409485 0409486 0409992 0409995 0409996 0409997 0410009 0379496 0379497 0382688 0384407 0394883 0394892 0394894 0367009 0371356 0379346 0384407 0387817 0367009 0395420 0380864 0362676 0391416 0360422 0367009 0368228 0371356 0379166 0379346 0380864 0382774 0386513 0388038 0389912 0390124 0391416 0394138 0400209 0404461 0380864 0368228 0384722 0387051 0380864 0380864 0350991 0357056 0361676 0365399 0367009 0368228 0377761 0380864 0384722 0386513 0390124 0394138 0394380 0394654 0368228 0380864 0404786 0390124 0387051 0349046 0349527 0352252 0360448 0364804 0365399 0366800 0368585 0371356 0372632 0375719 0377761 0379346 0380567 0380758 0380864 0381539 0384722 0387508 0387817 0389697 0389912 0390124 0390147 0392169 0393206 0393526 0394312 0394380 0394654 0396688 0402930 0404374 0393206 0387051 0391416 0392169 0363706 0364338 0371356 0382947 0384722 0392169 0406187 0407176 0349333 0362957 0363706 0368581 0370372 0371356 0377761 0380754 0381076 0382339 0384722 0388038 0389046 0390124 0391060 0392169 0393761 0394015 0394312 0396688 0406070 0380505 0389046 0354566 0356480 0358943 0373161 0399623 0391272 0399623 0391272 0385261 0386746 0385261 0363706 0366800 0366802 0368581 0368585 0371356 0380754 0381539 0382339 0388038 0388856 0389371 0390147 0393761 0394312 0398208 0380505 0398208 0363706 0363778 0364338 0366802 0368581 0369332 0378667 0381748 0382339 0385261 0388038 0388530 0388856 0389697 0403307 0405316 0408287 0388856 0361320 0363706 0366802 0381076 0404496 0366802 0381076 0363706 0369332 0381076 0381748 0406528 0389697 0370372 0358943 0368879 0369332 0370372 0378279 0386285 0386631 0387440 0389697 0401843 0406187 0409595 0386285 0386631 0368879 0366903 0401843 0378279 0356077 0358943 0366903 0367878 0378279 0399290 0358943 0366903 0373461 0386366 0391318 0386239 0386239 0391318 0369515 0381033 0399529 0381033 0369515 0382083 0408575 0410038 0408545 0408548 0408549 0408551 0408552 0408556 0408557 0408559 0408561 0408562 0408563 0408564 0408566 0408567 0408568 0408572 0410000 0410003 0410005 0410006 0410010 0410011 0410012 0410013 0410014 0410021 0410023 0410026 0410027 0410032 0410035 0410036 0384698 0374276 0384698 0359109 0359109 0385519 0357253 0369326 0371914 0379256 0362070 0389165 0389174 0389559 0390877 0406656 0375624 0389043 0390877 0395563 0398015 0402663 0405680 0409170 0409331 0360751 0363002 0375624 0389165 0389469 0390962 0392527 0393758 0395160 0395382 0396588 0396772 0397371 0406507 0407078 0410316 0349549 0354136 0392052 0392052 0386359 0391609 0391609 0384742 0390822 0390822 0390822 0385919 0385919 0385919 0390822 0390822 0401752 0401752 0389208 0389208 0353398 0353398 0395793 0395793 0395793 0395793 0408132 0362868 0362868 0408092 0408098 0408104 0408106 0408108 0408109 0408112 0408121 0408123 0408125 0408126 0408127 0408131 0408270 0388851 0390649 0401777 0356392 0380680 0388851 0400670 0384734 0386866 0367047 0367047 0368258 0387412 0387412 0389503 0406922 0366709 0384829 0366709 0384845 0357997 0389503 0366709 0389503 0390475 0406922 0402353 0384845 0386279 0387641 0360671 0389503 0387641 0368967 0361445 0405294 0368967 0387641 0389503 0389503 0368967 0369511 0386279 0393604 0369511 0369511 0393604 0361445 0390391 0390391 0391674 0367965 0374654 0379809 0379812 0379814 0379823 0388302 0388304 0394315 0394316 0394317 0394318 0394319 0394320 0394321 0394322 0394323 0394324 0394325 0394326 0394327 0394328 0394329 0394330 0394331 0394334 0394335 0394336 0394337 0396752 0396755 0396757 0396760 0396761 0396786 0396788 0396791 0396795 0396796 0396799 0396800 0396811 0396812 0396819 0396832 0396834 0396838 0396839 0401284 0401285 0401286 0401287 0401288 0401289 0401290 0401291 0401292 0401293 0401294 0401295 0401296 0401308 0401309 0401311 0401314 0401315 0403881 0403882 0403884 0403885 0403886 0403887 0403888 0403890 0403891 0403892 0403893 0403894 0403895 0403896 0403897 0403898 0403901 0403902 0403903 0403904 0403905 0403907 0403908 0403909 0403910 0409124 0409125 0409126 0409127 0409129 0409131 0379823 0396780 0396793 0396809 0396831 0402979 0404976 0393055 0402979 0358989 0365946 0399776 0404124 0408612 0358989 0360992 0360992 0402979 0360992 0402979 0392886 0353140 0360992 0393055 0360992 0392202 0355828 0377903 0355828 0393055 0393439 0409335 0393439 0351750 0353140 0355822 0355821 0355822 0355828 0392202 0355903 0355821 0355821 0366633 0392219 0392219 0392219 0366633
Product Distributed Qty 2350 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.

Event Detail

Event Id 62416
Product Type Drugs
Status Ongoing
Recalling Firm Franck's Lab Inc., d.b.a. Franck's Compounding Lab
City Ocala
State FL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-05-25
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and West Indies
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