RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS I ___________________________________ PRODUCT Alcohol-Free Mouthwash, a yellow liquid in a 4 oz. (118 mL) plastic bottle, 60 bottles per case; Made in USA; product code AG-210, bar code (01) 0 0380470 07119 0. Product was sold in cases of 60 bottles, but was also packaged as a component into custom ordered hospital admission kits, Recall # D-280-2008 CODE Lots: 26228 and 26230 RECALLING FIRM/MANUFACTURER Hydrox Chemical Co., Elgin, IL, by letters and press releases on May 1, 2008, May 2, 2008, May 5, 2008 and May 16, 2008. Firm initiated recall is ongoing. REASON Microbial contamination of a non-sterile product. The alcohol-free mouthwash was found to be contaminated with Burkholderia cepacia bacteria. VOLUME OF PRODUCT IN COMMERCE 126,960 bottles DISTRIBUTION Nationwide ___________________________________ PRODUCT Solodyn? Extended Release Tablets (Minocycline HCl USP) 90mg, 30 count bottles, Rx only, NDC 99207-461-30, Recall # D-281-2008 CODE Lots B080037, Expiration Date 12/09 and B080038, Expiration Date: 12/09 RECALLING FIRM/MANUFACTURER Recalling Firm: Medicis Pharmaceutical Corp., Scottsdale, AZ, by telephone on May 8, 2008 and by press release and letters on May 13, 2008, and May 16, 2008. Manufacturer: aaiPharma, Inc., Wilmington, NC. Firm initiated recall is ongoing. REASON Adulterated Presence of Foreign Tablets; bottles labeled to contain Solodyn? Extended Release Tablets (Minocycline HCl) 90mg actually contain Azasan? 75 mg Tablets (Azathioprine) VOLUME OF PRODUCT IN COMMERCE 37,504 ? 30 count bottles DISTRIBUTION AZ, CA, CO, HI, IL, OH, UT, WA and PR ___________________________________ PRODUCT a) Heparin Sodium 25,000 Units in 5% Dextrose Injection, 250mL (NDC 0264-9587-20) and 500mL (NDC 0264-9577-10) EXCEL Containers packaged 24 per case, Recall # D-282-2008; b) Heparin Sodium 1000 Units in 0.9% Sodium Chloride Injection in Full Fill 500mL EXCEL Containers, NDC 0264-9872-10, CAN DIN 01935933, Recall # D-283-2008; c) Heparin Sodium 20,000 Units in 5% Dextrose Injection, 500mL (CAN DIN 02209713) EXCEL Containers packaged 24 per case, Recall # D-284-2008; d) Heparin Sodium 25,000 Units in 5% Dextrose Injection, in 250mL (CAN DIN 02209721) and 500mL (CAN DIN 01935941) EXCEL Containers packaged 24 per case, Recall # D-285-2008 CODE a) Lot numbers: J7D490, J7C470, J7E494, J7N556, J7P476, Lot numbers: J7C684, J7D496, J7E500, J7P404, J7N604; b) Lot numbers: J7C611, J7C557, J7C477, J7C705, J7D485, J7E415, J7E416, J7E489, J7N519, J7N676; c) Lot numbers: J7D580; d) Lot number: J7E420, Lot number: J7E577 RECALLING FIRM/MANUFACTURER B, Braun Medical, Inc., Irvine, CA, by letter beginning March 20, 2008 and by press release on March 21, 2008. Firm initiated recall is ongoing. REASON Presence of foreign substance; active pharmaceutical ingredient found to be contaminated with over-sulfated chondroitin sulfate. VOLUME OF PRODUCT IN COMMERCE 386,606 units DISTRIBUTION Nationwide and Canada ___________________________________ PRODUCT a) Digitek (digoxin tablets, USP) 125 mcg (0.125 mg), 100, 1000 and 5000 tablets bottles, Rx only, NDC 62794-145-01, Recall # D-286-2008; b) Digitek (digoxin tablets USP), 250 mcg (0.25 mg), 100, 1000 and 5000 tablet bottles, Rx only, NDC: 62794-146-01, Recall # 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) 146 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 RECALLING FIRM/MANUFACTURER Actavis Totowa LLC, Totowa, NJ, by letters on April 26, 2008 and April 30, 2008. Firm initiated recall is ongoing. REASON Superpotent; Tablets have a thickness approximately double to that required. VOLUME OF PRODUCT IN COMMERCE 166 lots DISTRIBUTION Nationwide