{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-04-01", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "country": "United States", "city": "Ocala", "address_1": "1210 SW 33rd Avenue", "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.", "address_2": "", "product_quantity": "434 units", "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", "center_classification_date": "20120810", "distribution_pattern": "Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies", "state": "FL", "product_description": "LIDOCAINE HCL (STERILE) 4% JELLY\t120 ML \t \t \t \t \t30 ML; \t LIDOCAINE HCL 4% SOLUTION\t200 ML \t300 ML \t500 ML \t \t \t \t600 ML; \t LIDOCAINE HCL 1% INJECTABLE\t100 ML \t \t \t \t \t1000 ML \t \t \t \t \t \t \t \t \t1200 ML \t \t \t \t \t \t \t \t \t \t \t1250 ML \t \t150 ML \t \t \t \t \t1500 ML \t \t180 ML \t \t20 ML \t200 ML \t \t \t \t \t2000 ML \t240 ML \t250 ML \t \t \t \t2500 ML \t \t300 ML \t \t \t \t \t \t350 ML \t360 ML \t \t400 ML \t480 ML \t \t50 ML \t500 ML \t \t \t \t \t \t \t \t \t \t \t60 ML \t600 ML \t \t \t \t720 ML \t \t750 ML \t7500 ML \t90 ML; LIDOCAINE HCL 10% INJECTABLE\t1000 ML; LIDOCAINE HCL IN BSS - P.F. OPHTHALMIC 1% INJECTABLE\t30 ML; LIDOCAINE HCL W/EPI (25X30ML) MDV *** 1%-1:100000 INJECTABLE\t150 MLS \t180 MLS \t50 VIALS; LIDOCAINE HCL, AQUEOUS 2% INJECTABLE\t100 ML \t \t \t \t1000 ML \t \t \t120 ML \t1200 GM \t1200 ML \t \t \t \t \t \t \t \t150 ML \t \t1500 ML \t20 ML \t200 ML \t \t2000 ML \t240 ML \t250 ML \t \t \t \t \t2500 ML \t \t300 ML \t \t \t \t40 ML \t \t450 ML \t480 ML \t \t50 ML \t \t \t \t \t500 ML \t \t \t \t \t \t \t \t \t \t600 ML \t \t \t \t \t80 ML; LIDOCAINE HCL, AQUEOUS PF 2% INJECTABLE\t1200 ML \t1500 ML \t1600 ML \t200 ML \t250 ML \t50 ML \t500 ML \t600 ML \t \t \t \t900 ML; LIDOCAINE HCL, AQUEOUS, BUFFERED, P.F. 2% INJECTABLE\t1000 ML \t500 ML; \t \t \t LIDOCAINE HCL, P.F. 0.5% INJECTABLE\t1000 ML; LIDOCAINE HCL, P.F. 1% INJECTABLE\t100 ML \t \t \t12 ML \t \t \t120 ML \t \t \t \t \t \t125 ML \t150 ML \t24 ML \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t240 ML \t2500 ML \t2670 ML \t30 ML \t300 ML \t \t40 ML \t48 ML \t \t \t50 ML \t \t \t6 ML \t \t \t \t60 ML \t \t \t \t \t \t \t \t720 ML \t80 ML \t900 ML; LIDOCAINE HCL, P.F. 4% INJECTABLE\t100 ML \t1000 ML \t125 ML \t225 ML \t240 ML \t75 ML LIDOCAINE HCL/METHYLCELLULOSE 1%/2% JELLY\t2 ML; LIDOCAINE HCL/METHYLCELLULOSE 2%/2% JELLY\t1000 ML \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t1000 MLS \t12000 ML \t200 ML \t2000 ML \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t2000 MLS \t \t3000 ML \t \t \t \t \t \t \t \t \t \t \t \t \t4000 ML \t \t \t \t \t \t \t \t \t \t \t500 ML \t \t5000 ML \t \t \t \t \t \t \t6000 ML \t \t \t \t \t \t \t750 ML; LIDOCAINE HCL/METHYLCELLULOSE 4%/2% JELLY\t1000 ML; LIDOCAINE HCL/METHYLCELLULOSE 5%/2% JELLY\t1000 ML; \t LIDOCAINE HCL/METHYLCELLULOSE 8%/2% JELLY\t1000 ML (111 DIFFERENT PRODUCTS)", "report_date": "20120822", "classification": "Class II", "openfda": {}, "recalling_firm": "Franck's Lab Inc., d.b.a. Franck's Compounding Lab", "recall_number": "D-1558-2012", "initial_firm_notification": "Letter", "product_type": "Drugs", "event_id": "62443", "termination_date": "20140815", "more_code_info": "", "recall_initiation_date": "20120521", "postal_code": "34474-5138", "voluntary_mandated": "Voluntary: Firm initiated", "status": "Terminated" } ] }