NRAC Issue #1694 ADDENDUM August 12, 2008 NATIONAL RECALL ALERT CENTER - IMMEDIATE WARNING ALERT NOTIFICATION THE FOLLOWING HAVE BEEN RECALLED OR ARE SUBJECT TO FIELD CORRECTION THIS LISTING IS ISSUED BY - NATIONAL RECALL ALERT CENTER, WASHINGTON, D.C. --------------------------------------------------------------------------- Route To ____________________________________ Status ______________________ THE FOLLOWING IS A CLASS I RECALL. THERE IS A REASONABLE PROBABILITY THAT THE USE OF THE AFFECTED PRODUCT MAY CAUSE SERIOUS INJURY OR DEATH IF THE PROBLEM IS NOT CORRECTED PRODUCT a) Digitek (digoxin tablets, USP) 125 mcg (0.125 mg), 100, 1000 and 5000 tablets bottles, Rx only, NDC 62794-145-01 RECALL NUMBER # D-286-2008 PRODUCT b) Digitek (digoxin tablets USP), 250 mcg (0.25 mg), 100, 1000 and 5000 tablet bottles, Rx only, NDC: 62794-146-01 RECALL NUMBER # D-287-2008 CODE a) 60236A1 (100 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Apr-08 60371A1 (100 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Apr-08 60372A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Apr-08 60373A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Apr-08 30399A1 (5000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg May-08 60400A1 (5000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg May-08 60401A1 (5000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg May-08 60402A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg May-08 60416A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg May-08 60605A1 (100 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Jun-08 60606A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Jun-08 60607A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Jun-08 0608A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Jul-08 60643A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Jul-08 60644A1 (100 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Jul-08 60645A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Jul-08 60756A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Sep-08 60757A1 (100 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Sep-08 60758A1 (100 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Sep-08 60759A1 (100 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Sep-08 60776A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Sep-08 60777A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Sep-08 60929A1 (5000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Oct-08 60930A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Oct-08 60931A1 (100 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Oct-08 60932A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Oct-08 60991A1 (100 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Nov-08 60992A1 (100 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Nov-08 60993A1 (100 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Nov-08 60994A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Nov-08 61092A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Dec-08 70023A1 (100 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Jan-09 70024A1 (100 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Jan-09 70025A1 (5000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Jan-09 70026A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Jan-09 70027A1 (5000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Jan-09 70078A1 (100 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Jan-09 70079A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Jan-09 70080A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Jan-09 70081A1 (100 count), 70081A2 (100 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Jan-09 70082A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Jan-09 70134A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Feb-09 70135A1 (5000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Feb-09 70136A1 (5000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Feb-09 70147A1 (5000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Feb-09 70149A1 (5000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Feb-09 70160A1 (100 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Feb-09 70161A1 (100 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Feb-09 70207A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Mar-09 70208A1 (5000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Mar-09 70209A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Mar-09 70296A1 (100 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Apr-09 70297A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Apr-09 70298A1 (100 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Apr-09 70299A1 (5000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Apr-09 70300A1 (5000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Apr-09 70557A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Jul-09 70558A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Jul-09 70559A1 (5000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Jul-09 70560A1 (100 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Jul-09 70600A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Jul-09 70601A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Jul-09 70736A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Sep-09 70737A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Sep-09 70738A1 (5000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Sep-09 70753A1 (5000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Sep-09 70766A1 (100 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Sep-09 70767A1 (100 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Sep-09 70768A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Sep-09 70769A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Sep-09 70770A1 (5000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Sep-09 70924A2 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Nov-09 70925A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Nov-09 70926A1 (5000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Nov-09 70949A1 (100 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Nov-09 70950A1 (100 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Nov-09 70951A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Nov-09 70952A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Nov-09 70953A1 (5000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Nov-09 71004A1 (5000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Dec-09 71005A1 (100 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Dec-09 80044A1 (100 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Jan-10 80045A1 (5000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Jan-10 80046A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Jan-10 80047A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Jan-10 80189A1 (100 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Feb-10 80190A1 (100 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Mar-10 80227A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Mar-10 60776A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Sep-08 60777A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Sep-08 60929A1 (5000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Oct-08 60930A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Oct-08 60931A1 (100 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Oct-08 60932A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Oct-08 60991A1 (100 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Nov-08 60992A1 (100 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Nov-08 60993A1 (100 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Nov-08 60994A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Nov-08 61092A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Dec-08 70023A1 (100 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Jan-09 70024A1 (100 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Jan-09 70025A1 (5000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Jan-09 70026A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Jan-09 70027A1 (5000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Jan-09 70078A1 (100 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Jan-09 70079A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Jan-09 70080A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Jan-09 70081A1 (100 count), 70081A2 (100 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Jan-09 70082A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Jan-09 70134A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Feb-09 70135A1 (5000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Feb-09 70136A1 (5000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Feb-09 70147A1 (5000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Feb-09 70149A1 (5000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Feb-09 70160A1 (100 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Feb-09 70161A1 (100 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Feb-09 70207A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Mar-09 70208A1 (5000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Mar-09 70209A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Mar-09 70296A1 (100 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Apr-09 70297A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Apr-09 70298A1 (100 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Apr-09 70299A1 (5000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Apr-09 70300A1 (5000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Apr-09 70557A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Jul-09 70558A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Jul-09 70559A1 (5000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Jul-09 70560A1 (100 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Jul-09 70600A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Jul-09 70601A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Jul-09 70736A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Sep-09 70737A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Sep-09 70738A1 (5000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Sep-09 70753A1 (5000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Sep-09 70766A1 (100 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Sep-09 70767A1 (100 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Sep-09 70768A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Sep-09 70769A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Sep-09 70770A1 (5000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Sep-09 70924A2 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Nov-09 70925A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Nov-09 70926A1 (5000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Nov-09 70949A1 (100 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Nov-09 70950A1 (100 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Nov-09 70951A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Nov-09 70952A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Nov-09 70953A1 (5000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Nov-09 71004A1 (5000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Dec-09 71005A1 (100 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Dec-09 80044A1 (100 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Jan-10 80045A1 (5000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Jan-10 80046A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Jan-10 80047A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Jan-10 80189A1 (100 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Feb-10 80190A1 (100 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Mar-10 80227A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Mar-10 b) 60319A1 (100 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Apr-08 60320A1 (1000 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Apr-08 60321A1 (100 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Apr-08 60322A1 (1000 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Apr-08 60323A1 (100 count) 146 Digitek (digoxin tablets, USP) 0.25 mg May-08 61098A1 (5000 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Dec-08 61099A1 (1000 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Dec-08 61100A1 (100 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Dec-08 61101A1 (100 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Dec-08 61102A1 (100 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Dec-08 61103A1 (100 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Dec-08 61104A1 (100 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Dec-08 70120A1 (1000 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Feb-09 70121A1 (5000 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Feb-09 70122A1 (1000 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Feb-09 70174A1 (100 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Feb-09 70175A1 (5000 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Mar-09 70176A1 (100 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Mar-09 70370A1 (1000 count) 146 Digitek (digoxin tablets, USP) 0.25 mg May-09 70371A1 (1000 count) 146 Digitek (digoxin tablets, USP) 0.25 mg May-09 70372A1 (5000 count) 146 Digitek (digoxin tablets, USP) 0.25 mg May-09 70386A1 (5000 count) 146 Digitek (digoxin tablets, USP) 0.25 mg May-09 70454A1 (5000 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Jun-09 70455A1 (1000 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Jun-09 70456A1 (1000 count) 46 Digitek (digoxin tablets, USP) 0.25 mg Jun-09 70457A1 (1000 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Jun-09 70458A1 (5000 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Jun-09 70551A1 (100 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Jul-09 70664A1 (100 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Aug-09 70665A1 (1000 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Aug-09 70666A1 (1000 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Aug-09 70670A1 (100 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Aug-09 70671A1 (1000 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Aug-09 70672A1 (5000 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Aug-09 70673A1 (100 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Aug-09 70811A1 (100 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Oct-09 70812A1 (100 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Oct-09 70813A1 (1000 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Oct-09 70832A1 (5000 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Oct-09 70833A1 (5000 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Oct-09 70834A1 (5000 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Oct-09 70835A1 (100 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Oct-09 70836A1 (1000 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Oct-09 71032A1 (5000 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Dec-09 71033A1 (1000 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Dec-09 71034A1 (5000 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Dec-09 71035A1 (5000 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Dec-09 71036A1 (100 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Jan-10 71054A1 (100 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Jan-10 80002A1 (100 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Jan-10 80003A1 (100 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Jan-10 80108A1 (100 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Feb-10 80109A1 (1000 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Feb-10 80110A1 (5000 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Feb-10 80111A1 (5000 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Feb-10) 80112A1 (1000 count 146 Digitek (digoxin tablets, USP) 0.25 mg Feb-10 60497A1 (5000 count) 146 Digitek (digoxin tablets, USP) 0.25 mg May-08 60498A1 (5000 count) 146 Digitek (digoxin tablets, USP) 0.25 mg May-08 60499A1 (5000 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Jun-08 60511A1 (100 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Jun-08 60512A1 (1000 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Jun-08 60513A1 (1000 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Jun-08 60514A1 (100 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Jun-08 60515A1 (1000 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Jun-08 60677A1 (100 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Aug-08 60678A1 (100 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Aug-08 60679A1 (1000 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Aug-08 60680A1 (1000 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Aug-08 60681A1 (1000 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Aug-08 60863A1 (100 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Oct-08 60864A1 (100 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Oct-08 60865A1 (1000 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Oct-08 61053A1 (1000 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Nov-08 61054A1 (1000 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Nov-08 61055A1 (1000 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Dec-08 61056A1 (100 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Dec-08 61057A1 (5000 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Dec-08 61097A1 (100 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Dec-08 MANUFACTURED & RECALLED BY Actavis Totowa LLC, Totowa, NJ QUANTITY 166 lots DISTRIBUTION Nationwide REASON Superpotent; Tablets have a thickness approximately double to that required. --------------------------------------------------------------------------- Route To ____________________________________ Status ______________________ PRODUCT a) VECTRA GENISYS, electromechanical therapeutic ultrasound device, Model No. 2759, Chattanooga Group RECALL NUMBER # Z-1636-2008 PRODUCT b) INTELECT LEGEND XT, electromechanical therapeutic ultrasound and powered muscle stimulation device, Model No. 2760, Chattanooga Group RECALL NUMBER # Z-1637-2008 PRODUCT c) VECTRA GENISYS, electromechanical therapeutic ultrasound and powered muscle stimulation device, Model No. 2761, Chattanooga Group RECALL NUMBER # Z-1638-2008 PRODUCT d) INTELECT TRANSPORT ULTRASOUND, electromechanical therapeutic ultrasound device, Model No. 2782, Chattanooga Group RECALL NUMBER # Z-1638-2008 CODE a) Serial numbers: 1000, 1002, 1003, 1004, 1005, 1007, 1008, 1010, 1011, 1012, 1013, 1014, 1015, 1016, 1017, 1018, 1019, 1021, 1025, 1026, 1028, 1029, 1030, 1031, 1032, 1034, 1035, 1036, 1037, 1039, 1040, 1042, 1043, 1044, 1045, 1046, 1047, 1050, 1051, 1054, 1056, 1058, 1059, 1060, 1061, 1062, 1064, 1066, 1067, 1069, 1071, 1073, 1074, 1075, 1076, 1077, 1078, 1079, 1081, 1082, 1083, 1085, 1086, 1087, 1088, 1089, 1091, 1095, 1096, 1097, 1100, 1102, 1103, 1112, 1114, 1120, 1121, 1122, 1123, 1124, 1125, 1130, 1135, 1137, 1138, 1141, 1142, 1143, 1145, 1146, 1147, 1148, 1149, 1150, 1153, 1157, 1158, 1162, 1163, 1168, 1169, 1171, 1176, 1177, 1178, 1180, 1181, 1186, 1191, 1193, 1194, 1195, 1196, 1197, 1198, 1200, 1201, 1203, 1206, 1207, 1208, 1209, 1210, 1211, 1213, 1215, 1216, 1217, 1220, 1221, 1222, 1225, 1226, 1227, 1228, 1229, 1231, 1232, 1233, 1235, 1236, 1237, 1238, 1239, 1240, 1241, 1247, 1248, 1249, 1254, 1255, 1256, 1259, 1261, 1262, 1266, 1269, 1273, 1275, 1277, 1278, 1279, 1280, 1281, 1282, 1283, 1285, 1286, 1289, 1291, 1293, 1294, 1295, 1296, 1300, 1301, 1302, 1303, 1304, 1305, 1307, 1308, 1309, 1310, 1313, 1314, 1319, 1320, 1329, 1330, 1333, 1339, 1341, 1344, 1346, 1348, 1349, 1351, 1359, 1360, 1361, 1362, 1363, 1364, 1369, 1370, and 1373 b) Serial numbers: 1017, 1022, 1028, 1031, 1035, 1040, 1041, 1043, 1046, 1048, 1049, 1050, 1053, 1055, 1056, 1058, 1059, 1061, 1062, 1065, 1066, 1067, 1071, 1072, 1074, 1076, 1080, 1081, 1085, 1086, 1087, 1088, 1089, 1091, 1092, 1093, 1094, 1095, 1098, 1100, 1101, 1104, 1105, 1107, 1108, 1111, 1114, 1135, 1136, 1138, 1139, 1157, 1158, 1160, 1162, 1163, 1164, 1167, 1168, 1169, 1171, 1172, 1174, 1177, 1201, 1202, 1203, 1206, 1207, 1212, 1213, 1214, 1220, 1224, 1225, 1238, 1243, 1245, 1252, 1253, 1254, 1255, 1256, 1257, 1258, 1259, 1260, 1262, 1264, 1265, 1266, 1269, 1271, 1272, 1273, 1274, 1275, 1278, 1279, 1285, 1288, 1289, 1290, 1311, 1313, 1314, 1316, 1317, 1321, 1322, 1324, 1326, 1327, 1328, 1329, 1330, 1331, 1333, 1334, 1338, 1340, 1341, 1342, 1344, 1349, 1350, 1351, 1353, 1354, 1359, 1361, 1362, 1364, 1367, 1368, 1389, 1390, 1392, 1393, 1394, 1395, 1397, 1400, 1401, 1403, 1404, 1405, 1406, 1411, 1413, 1422, 1424, 1432, 1439, 1440, 1447, 1448, 1450, 1454, 1460, 1461, 1463, 1465, 1467, 1469, 1542, 1550, 1556, 1558, 1560, 1566, 1568, 1570, 1571, 1573, 1574, 1576, 1589, 1602, 1604, 1605, 1606, 1607, 1610, 1611, 1613, 1614, 1616, 1618, 1619, 1621, 1622, 1623, 1625, 1626, 1628, 1629, 1632, 1633, 1635, 1641, 1643, 1644, 1646, 1647, 1651, 1654, 1655, 1657, 1659, 1660, 1662, 1663, 1665, 1691, 1697, 1699, 1701, 1703, 1704, 1705, 1706, 1712, 1713, 1719, 1720, 1727, 1729, 1730, 1754, 1759, 1760, 1763, 1766, 1773, 1775, 1776, 1777, 1780, 1781, 1782, 1784, 1785, 1786, 1792, 1793, 1798, 1799, 1802, 1809, 1813, 1819, 1820, 1821, 1825, 1830, 1832, 1834, 1835, 1842, 1846, 1850, 1852, 1855, 1859, 1861, 1865, 1907, 1909, 1910, 1911, 1914, 1918, 1921, 1925, 1926, 1927, 1928, 1929, 1933, 1934, 1938, 1940, 1974, 1978, 1979, 1983, 1984, 1985, 1988, 1990, 1995, 1996, 1998, 2000, 2008, 2010, 2011, 2012, 2021, 2022, 2024, 2032, 2035, 2036, 2037, 2038, 2040, 2041, 2045, 2046, 2049, 2050, 2052, 2056, 2057, 2058, 2059, 2063, 2064, 2067, 2074, 2075, 2076, 2078, 2079, 2082, 2083, 2089, 2090, 2092, 2093, 2094, 2097, 2099, 2100, 2104, 2172, 2173, 2174, 2181, 2185, 2189, 2190, 2191, 2194, 2196, 2199, 2202, 2204, 2205, 2209, 2212, 2213, 2214, 2216, 2218, 2219, 2221, 2223, 2224, 2225, 2230, 2235, 2238, 2243, 2247, 2248, and 2282 c) Serial numbers: 1037, 1038, 1041, 1042, 1045, 1049, 1050, 1055, 1056, 1061, 1062, 1063, 1064, 1066, 1067, 1068, 1071, 1073, 1074, 1075, 1076, 1117, 1119, 1122, 1123, 1124, 1128, 1129, 1130, 1131, 1132, 1133, 1135, 1137, 1138, 1139, 1140, 1141, 1143, 1144, 1145, 1146, 1148, 1149, 1150, 1153, 1155, 1156, 1207, 1208, 1209, 1212, 1215, 1222, 1223, 1224, 1226, 1228, 1229, 1230, 1231, 1232, 1233, 1234, 1235, 1236, 1238, 1240, 1242, 1244, 1245, 1247, 1248, 1250, 1251, 1253, 1254, 1256, 1257, 1258, 1260, 1262, 1265, 1266, 1362, 1364, 1365, 1366, 1370, 1372, 1374, 1375, 1377, 1378, 1381, 1382, 1383, 1384, 1413, 1414, 1415, 1416, 1417, 1421, 1422, 1424, 1425, 1427, 1428, 1429, 1430, 1433, 1434, 1435, 1436, 1464, 1467, 1468, 1470, 1472, 1473, 1474, 1480, 1481, 1485, 1486, 1487, 1489, 1491, 1492, 1493, 1494, 1495, 1497, 1499, 1500, 1502, 1503, 1504, 1505, 1507, 1508, 1509, 1510, 1563, 1565, 1570, 1573, 1574, 1578, 1579, 1586, 1612, 1613, 1615, 1616, 1616, 1617, 1618, 1619, 1620, 1625, 1626, 1627, 1630, 1632, 1634, 1635, 1636, 1638, 1639, 1642, 1643, 1644, 1645, 1667, 1668, 1669, 1670, 1672, 1673, 1675, 1677, 1679, 1680, 1683, 1685, 1737, 1738, 1741, 1742, 1743, 1744, 1745, 1746, 1747, 1748, 1749, 1753, 1754, 1755, 1756, 1757, 1759, 1761, 1762, 1763, 1764, 1765, 1767, 1775, 1776, 1777, 1779, 1780, 1784, 1785, 1787, 1788, 1789, 1790, 1791, 1818, 1819, 1820, 1821, 1822, 1826, 1828, 1830, 1832, 1834, 1835, 1836, 1838, 1840, 1846, 1847, 1848, 1852, 1853, 1855, 1857, 1858, 1861, 1862, 1864, 1865, 1867, 1868, 1869, 1870, 1872, 1874, 1876, 1878, 1881, 1882, 1887, 1889, 1891, 1892, 1894, 1898, 1900, 1902, 1954, 1956, 1957, 1961, 1964, 1965, 1967, 1972, 1975, 1976, 1977, 1979, 1980, 1983, 1985, 1989, 1990, 1992, 1995, 1996, 1997, 1998, 2000, 2001, 2005, 2007, 2008, 2011, 2012, 2013, 2014, 2017, 2018, 2019, 2020, 2025, 2028, 2036, 2037, 2039, 2041, 2118, 2128, 2129, 2131, 2133, 2136, 2139, 2141, 2144, 2145, 2146, 2148, 2150, 2152, 2156, 2158, 2160, 2162, 2163, 2164, 2166, 2168, 2170, 2172, 2175, 2177, 2181, 2186, 2187, 2197, 2198, 2199, 2201, 2203, 2205, 2207, 2211, 2214, 2217, 2222, 2223, 2224, 2227, 2230, 2237, 2239, 2240, 2241, 2246, 2248, 2253, 2254, 2256, 2259, 2260, 2290, 2293, 2295, 2296, 2298, 2303, 2376, 2378, 2381, 2383, 2384, 2391, 2392, 2393, 2394, 2396, 2397, 2398, 2399, 2401, 2402, 2404, 2407, 2411, 2412, 2414, 2417, 2419, 2425, 2432, 2435, 2436, 2439, 2445, 2446, 2448, 2453, 2457, 2458, 2461, 2464, 2469, 2475, 2478, 2481, 2482, 2490, 2494, 2498, 2505, 2575, 2727, 2731, 2735, 2740, 2747, 2750, 2756, 2763, 2776, 2778, 2779, 2784, 2792, 2793, 2796, 2814, 2815, 2816, 2819, 2867, 2889, 2892, 2898, 2982, 2988, 2989, 2990, 2994, 2995, 2999, 3000, 3003, 3005, 3006, 3008, 3009, 3011, 3013, 3014, 3015, 3018, 3021, 3083, 3092, and 3102 d) Serial numbers: 1000, 1001, 1004, 1005, 1008, 1009, 1010, 1011, 1014, 1016, 1017, 1019, 1021, 1022, 1023, 1028, 1029, 1032, 1033, 1034, 1037, 1039, 1041, 1042, 1043, 1044, 1045, 1046, 1049, 1050, 1053, 1054, 1057, 1059, 1061, 1062, 1064, 1065, 1066, 1067, 1068, 1069, 1070, 1073, 1076, 1077, 1078, 1079, 1080, 1081, 1085, 1086, 1087, 1088, 1089, 1090, 1092, 1093, 1094, 1096, 1097, 1099, 1100, 1101, 1103, 1105, 1107, 1113, 1114, 1115, 1116, 1117, 1120, 1122, 1124, 1126, 1130, 1131, 1132, 1133, 1134, 1135, 1137, 1138, 1141, 1143, 1145, 1146, 1147, 1149, 1150, 1152, 1153, 1155, 1157, 1158, 1161, 1163, 1164, 1165, 1166, 1167, 1168, 1171, 1172, 1173, 1174, 1175, 1176, 1177, 1182, 1184, 1186, 1189, 1190, 1191, 1192, 1194, 1195, 1196, 1198, 1199, 1203, 1204, 1207, 1208, 1209, 1212, 1213, 1214, 1216, 1218, 1220, 1221, 1222, 1223, 1224, 1225, 1226, 1229, 1230, 1232, 1233, 1235, 1236, 1237, 1240, 1242, 1243, 1244, 1245, 1246, 1247, 1248, 1249, 1250, 1251, 1252, 1253, 1254, 1255, 1256, 1257, 1258, 1260, 1261, 1263, 1264, 1265, 1267, 1268, 1270, 1271, 1273, 1276, 1278, 1279, 1282, 1284, 1287, 1288, 1294, 1300, 1301, 1303, 1306, 1307, 1308, 1309, 1310, 1311, 1313, 1314, 1315, 1316, 1318, 1321, 1323, 1325, 1326, 1327, 1328, 1329, 1330, 1331, 1332, 1334, 1336, 1337, 1338, 1339, 1340, 1341, 1343, 1344, 1346, 1347, 1350, 1351, 1353, 1354, 1357, 1358, 1362, 1365, 1367, 1368, 1369, 1371, 1372, 1376, 1377, 1382, 1384, 1386, 1387, 1389, 1390, 1391, 1392, 1394, 1396, 1398, 1399, 1400, 1401, 1403, 1404, 1405, 1406, 1407, 1408, 1409, 1411, 1412, 1413, 1414, 1415, 1417, 1418, 1419, 1421, 1422, 1425, 1426, 1427, 1428, 1431, 1432, 1433, 1434, 1436, 1437, 1439, 1440, 1441, 1443, 1444, 1445, 1446, 1448, 1449, 1450, 1453, 1455, 1458, 1459, 1460, 1462, 1463, 1464, 1473, 1474, 1475, 1476, 1477, 1478, 1479, 1480, 1483, 1484, 1485, 1488, 1489, 1490, 1491, 1492, 1493, 1495, 1496, 1497, 1498, 1499, 1500, 1504, 1506, 1513, 1518, 1522, 1524, 1525, 1526, 1529, 1533, 1534, 1535, 1536, 1537, 1540, 1541, 1542, 1544, 1546, 1548, 1551, 1552, 1554, 1555, 1557, 1558, 1559, 1560, 1562, 1563, 1564, 1565, 1570, 1572, 1573, 1575, 1577, 1578, 1579, 1581, 1582, 1587, 1588, 1591, 1593, 1594, 1595, 1597, 1600, 1602, 1606, 1607, 1608, 1610, 1611, 1612, 1613, 1614, 1615, 1616, 1617, 1618, 1623, 1624, 1626, 1628, 1629, 1630, 1634, 1635, 1637, 1638, 1639, 1641, 1643, 1645, 1647, 1648, 1649, 1650, 1651, 1652, 1653, 1655, 1656, 1657, 1658, 1659, 1660, 1661, 1664, 1665, 1667, 1668, 1671, 1672, 1675, 1676, 1677, 1678, 1679, 1683, 1684, 1687, 1688, 1689, 1690, 1695, 1697, 1699, 1700, 1701, 1702, 1705, 1706, 1707, 1710, 1711, 1713, 1714, 1717, 1720, 1721, 1722, 1724, 1725, 1726, 1729, 1730, 1731, 1732, 1733, 1737, 1738, 1743, 1744, 1746, 1747, 1749, 1750, 1752, 1753, 1754, 1756, 1758, 1761, 1767, 1768, 1770, 1772, 1776, 1778, 1779, 1780, 1782, 1785, 1786, 1788, 1789, 1790, 1792, 1798, 1799, 1802, 1804, 1810, 1813, 1815, 1819, 1821, 1822, 1823, 1826, 1827, 1829, 1833, 1836, 1837, 1841, 1843, 1844, 1845, 1847, 1848, 1850, 1852, 1876, 1878, 1879, 1880, 1884, 1887, 1888, 1889, 1892, and 1893 MANUFACTURED & RECALLED BY Chattanooga Corporation, Inc., Hixson, TN QUANTITY 1,565 units DISTRIBUTION Nationwide REASON Device may fail to administer therapy during use. ---------------------------------------------------------------------------