Drug Enforcement D-1643-2012

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
WATER BACT STERILE - (25X30ML)*** INJECTABLE 30 ML 750 MLS; WATER STERILE - USP (25X10ML)* INJECTABLE 10 ML 10 MLS 100 ML 100 MLS 1000 ML 110 ML 120 ML 130 ML 130 MLS 150 150 ML 150 MLS 160 ML 160 MLS 20 20 ML 200 ML 200 MLS 2000 ML 230 ML 240 ML 250 ML 250 MLS 30 ML 30 MLS 300 300 ML 300 MLS 40 ML 40 MLS 400 ML 400 MLS 50 50 ML 50 MLS 500 ML 500 MLS 60 60 ML 60 MLS 6800 ML 70 ML 7240 ML 7500 ML 80 ML 80 MLS 90 ML; WATER STERILE - USP (25X20ML)** INJECTABLE 1000 MLS 200 ML 200 MLS 300 MLS 400 MLS 500 ML 60 60 ML 600 20 600 ML; WATER STERILE - USP (25X50ML)** INJECTABLE 1000 ML 1150 ML 1250 MLS 1350 ML 150 MLS 2500 ML 300 ML 50 ML 500 ML 500 MLS 600 600 ML 600 MLS (72 DIFFERENT PRODUCTS)
Product quantity
311 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
—
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-1643-2012
Event ID
62443
Recall initiation date
May 21, 2012
Center classification date
August 10, 2012
Code info
Rx #'s: 0408845 0400308 0404146 0404314 0404734 0405632 0406573 0406701 0407236 0407894 0409557 0408043 0408222 0403792 0404381 0404597 0404937 0405274 0405602 0405880 0405881 0405889 0406307 0406538 0406558 0407551 0410050 0410051 0410054 0410335 0403801 0404660 0405429 0406714 0404383 0404424 0404429 0404431 0408668 0404381 0405641 0403996 0404175 0404381 0404598 0404985 0405057 0405274 0405520 0405687 0406286 0406538 0406573 0406905 0407288 0408084 0408783 0408855 0410229 0410380 0404381 0409102 0404479 0405889 0404597 0404661 0404881 0405520 0405836 0405881 0406558 0405174 0404381 0406372 0407748 0405429 0403860 0403862 0404014 0404169 0404533 0404735 0405599 0405896 0406440 0406612 0406750 0407072 0407940 0408312 0408462 0408930 0409264 0410399 0404881 0405639 0405654 0405882 0405883 0406752 0407396 0404682 0408308 0404383 0404381 0404328 0406996 0409438 0404660 0404183 0404435 0405283 0405348 0406510 0406660 0407382 0407748 0407844 0409421 0409755 0404159 0405637 0405926 0406895 0407005 0405084 0405180 0409839 0405174 0404014 0404171 0404187 0404314 0404526 0405237 0405472 0405522 0405871 0405896 0407001 0408598 0408601 0408761 0408821 0410024 0403801 0404159 0406339 0406752 0404659 0407005 0405884 0405897 0403788 0404014 0404184 0404624 0406610 0408898 0406161 0404937 0408175 0406989 0404001 0404002 0406671 0404133 0404146 0404171 0404172 0404182 0404381 0404435 0404526 0404529 0404530 0404531 0404533 0404608 0404620 0404732 0404846 0404875 0404904 0404979 0405171 0405347 0405348 0405687 0405879 0405910 0406151 0406207 0406286 0406491 0406520 0406560 0406612 0406680 0406892 0407001 0407240 0407580 0407585 0408487 0409058 0409077 0409494 0409554 0409582 0409590 0409592 0409846 0409848 0410323 0406325 0406895 0395514 0404133 0404314 0406829 0395514 0353249 0395514 0404533 0404598 0404734 0404742 0405676 0405887 0406902 0407236 0407462 0407757 0407802 0408372 0408752 0408833 0404479 0404381 0404531 0404573 0405522 0405925 0404617 0405428 0408161 0405428 0405428 0399738 0408376 0408385 0406368 0405178 0404163 0409151 0405049 0406485 0405049 0408044 0405181 0406845 0389952 0404159 0404163 0406848 0404833 0408322 0404829 0408324
More code info
—