Drug Enforcement D-1558-2012

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. 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 15, 2014

Product Information

Product description
LIDOCAINE HCL (STERILE) 4% JELLY 120 ML 30 ML; LIDOCAINE HCL 4% SOLUTION 200 ML 300 ML 500 ML 600 ML; LIDOCAINE HCL 1% INJECTABLE 100 ML 1000 ML 1200 ML 1250 ML 150 ML 1500 ML 180 ML 20 ML 200 ML 2000 ML 240 ML 250 ML 2500 ML 300 ML 350 ML 360 ML 400 ML 480 ML 50 ML 500 ML 60 ML 600 ML 720 ML 750 ML 7500 ML 90 ML; LIDOCAINE HCL 10% INJECTABLE 1000 ML; LIDOCAINE HCL IN BSS - P.F. OPHTHALMIC 1% INJECTABLE 30 ML; LIDOCAINE HCL W/EPI (25X30ML) MDV *** 1%-1:100000 INJECTABLE 150 MLS 180 MLS 50 VIALS; LIDOCAINE HCL, AQUEOUS 2% INJECTABLE 100 ML 1000 ML 120 ML 1200 GM 1200 ML 150 ML 1500 ML 20 ML 200 ML 2000 ML 240 ML 250 ML 2500 ML 300 ML 40 ML 450 ML 480 ML 50 ML 500 ML 600 ML 80 ML; LIDOCAINE HCL, AQUEOUS PF 2% INJECTABLE 1200 ML 1500 ML 1600 ML 200 ML 250 ML 50 ML 500 ML 600 ML 900 ML; LIDOCAINE HCL, AQUEOUS, BUFFERED, P.F. 2% INJECTABLE 1000 ML 500 ML; LIDOCAINE HCL, P.F. 0.5% INJECTABLE 1000 ML; LIDOCAINE HCL, P.F. 1% INJECTABLE 100 ML 12 ML 120 ML 125 ML 150 ML 24 ML 240 ML 2500 ML 2670 ML 30 ML 300 ML 40 ML 48 ML 50 ML 6 ML 60 ML 720 ML 80 ML 900 ML; LIDOCAINE HCL, P.F. 4% INJECTABLE 100 ML 1000 ML 125 ML 225 ML 240 ML 75 ML LIDOCAINE HCL/METHYLCELLULOSE 1%/2% JELLY 2 ML; LIDOCAINE HCL/METHYLCELLULOSE 2%/2% JELLY 1000 ML 1000 MLS 12000 ML 200 ML 2000 ML 2000 MLS 3000 ML 4000 ML 500 ML 5000 ML 6000 ML 750 ML; LIDOCAINE HCL/METHYLCELLULOSE 4%/2% JELLY 1000 ML; LIDOCAINE HCL/METHYLCELLULOSE 5%/2% JELLY 1000 ML; LIDOCAINE HCL/METHYLCELLULOSE 8%/2% JELLY 1000 ML (111 DIFFERENT PRODUCTS)
Product quantity
434 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. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, 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-1558-2012
Event ID
62443
Recall initiation date
May 21, 2012
Center classification date
August 10, 2012
Code info
Rx #'s: 0367755 0397544 0397544 0394203 0394203 0353087 0394203 0394203 0391064 0396617 0396618 0397379 0397665 0389435 0397604 0398197 0400182 0406428 0406441 0407299 0408671 0392392 0392866 0395109 0397604 0398121 0406401 0406428 0391064 0392866 0391064 0392394 0397379 0397401 0396330 0409785 0392392 0409993 0389435 0392394 0394007 0398254 0398371 0398197 0397564 0392532 0397401 0406158 0408033 0388839 0398070 0390935 0391064 0392392 0400496 0392394 0391064 0401695 0394973 0409350 0389048 0392392 0395192 0395322 0396495 0397014 0397235 0397286 0398200 0410339 0408395 0392392 0396495 0402468 0405322 0400938 0398892 0404270 0391064 0403246 0407249 0406513 0406511 0388935 0398116 0398651 0400184 0404681 0396015 0406879 0408191 0407760 0398152 0392177 0396015 0396776 0397935 0398690 0388570 0404681 0396331 0386589 0392123 0400499 0406879 0397574 0387654 0387657 0392123 0389739 0392177 0388570 0389520 0405648 0395417 0408169 0388570 0386589 0398344 0398897 0399058 0404400 0406370 0406409 0387654 0387657 0388315 0395460 0397237 0398140 0401098 0388570 0392120 0405324 0405865 0398386 0396384 0398522 0407403 0395328 0407403 0401899 0395328 0396384 0400983 0385425 0385425 0408240 0398953 0398955 0399006 0397926 0397701 0398953 0406581 0397701 0398955 0397926 0403958 0395327 0399741 0399741 0398231 0398955 0395209 0395209 0395209 0398953 0398955 0408343 0408356 0408359 0408361 0398953 0398955 0399741 0398953 0395327 0403237 0398228 0403237 0403822 0403955 0403237 0404870 0352507 0354115 0355699 0357889 0359365 0360370 0364979 0369341 0371280 0372079 0373472 0374032 0374306 0376181 0378274 0380074 0381850 0385344 0385547 0386110 0386788 0387127 0387422 0387464 0387859 0388713 0389087 0389291 0389369 0392010 0392179 0393703 0393791 0394288 0395465 0395688 0396321 0397535 0399096 0400643 0400805 0400842 0400849 0401048 0401101 0401253 0402339 0403298 0405184 0405477 0405647 0406833 0406870 0409282 0403815 0384363 0398902 0354644 0359373 0359556 0361151 0365492 0374306 0384183 0385520 0385547 0387466 0389030 0389369 0389936 0390088 0390875 0391203 0391252 0391254 0391255 0391808 0392555 0395499 0396125 0397244 0401048 0401553 0402814 0403285 0404205 0404211 0404219 0406766 0358069 0401639 0363813 0386485 0387583 0390418 0390538 0391203 0393542 0394622 0401048 0408256 0348902 0363945 0365492 0366731 0382057 0392179 0396006 0399798 0407366 0365954 0404604 0354990 0363945 0385338 0395499 0400889 0379753 0389066 0393699 0365954 0391256 0380645 0353540 0395979 0409426
More code info
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