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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 GENTAMICIN 40MG/ML (80MG/2ML) INJECTABLE 20 ML, 40 ML, 48 ML, 50 ML; GENTAMICIN / SODIUM BICARBONATE (STERILE) 480MG/LITER SOLUTION 1000 ML; GENTAMICIN /CLINDAMYCIN /POLYMIXIN B/STERILE WATER 0.1%/0.1%/0.05% SOLUTION 250 ML, 500 ML; GENTAMICIN DROPS (FORTIFIED) 14MG/ML (1.4%) OPHTHALMIC 10 ML; GENTAMICIN DROPS (FORTIFIED) 15MG/ML (1.5%) OPHTHALMIC 10 ML, 15 ML; GENTAMICIN DROPS (FORTIFIED) 18MG/ML (1.8%) OPHTHALMIC 5 ML; GENTAMICIN IRRIGATION 1GM/LITER SOLUTION 2000 ML; GENTAMICIN IRRIGATION 480MG/LITER SOLUTION 1000 ML, 2000 ML; GENTAMICIN***(80MGX2ML) 40MG/ML INJECTABLE 100 ML, 100 MLS, 100 VIAL, 12 ML, 14 ML, 150 ML, 200 ML, 25, 40 ML, 50 ML, 50 MLS, 50 VIALS (26 DIFFERENT PRODUCTS)
Recall Number D-1528-2012
Classification Class II
Code Info Rx #'s: 0402163 0401103 0361246 0374339 0400819 0401878 0376767 0357627 0358558 0385752 0387435 0388683 0398782 0389025 0389135 0394537 0400051 0410208 0389025 0388231 0391057 0405031 0393211 0393211 0388792 0384288 0407535 0378398 0378398 0377517 0378503 0378504 0380549 0381687 0383319 0385206 0390165 0390166 0390930 0392241 0396501 0396675 0397835 0398312 0398392 0398889 0402538 0402842 0405320 0408916 0378060 0378502 0385165 0399334 0399337 0399340 0399345 0399348 0408326 0405172 0396619 0393974 0378077 0380549 0385218 0399333 0399346 0399349 0399351 0399353 0399354 0399356 0399358 0399361 0399362 0392241 0405640 0402538 0396501 0377276 0377517 0377857 0378077 0379493 0380295 0380549 0380551 0381687 0385218 0387271 0387274 0387280 0387282 0389068 0390166 0390930 0391460 0391463 0391466 0391469 0391576 0391881 0392180 0392182 0392184 0395103 0395519 0396501 0404869 0409343 0409489 0409490 0409492 0410150 0410384 0367933 0395652 0396783 0408328 0402535
Product Distributed Qty 171 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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