NRAC Issue #1593 ADDENDUM August 29, 2006 --------------------------------------------------------------------------- Route To ____________________________________ Status ______________________ PRODUCT a) Levoxyl (r) (levoxyroxine sodium tablets, USP), 75 mcg 100 count bottles, Rx Only, NDA: 201-301 NDC: 52604-5075-1 RECALL NUMBER # D-332-6; PRODUCT b) Levoxyl (r) (levoxyroxine sodium tablets, USP), 112mcg, 100 and 1000-count bottles, Rx Only, NDA: 201-301 NDC: 52604-5112-1 and 52604-5112-2 RECALL NUMBER # D-333-6; PRODUCT c) Levoxyl (r) (levoxyroxine sodium tablets, USP), 125mcg, 100 and 1000-count bottles, Rx Only, NDA: 201-301 NDC: 52604-5125-2 and 52604-5112-2 RECALL NUMBER # D-334-6 CODE a) Lot: 7240, SAP batch 21272; b) Lots: 9227 and 9248, SAPs 21274 and 21324; c) Lots: 9222, 9228 and 9212. SAPs 21268, 21271 and 21267 MANUFACTURER King Pharmaceuticals, Inc. (St. Petersburg Facility), Saint Petersburg, FL. RECALLED BY King Pharmaceuticals, Inc., Bristol, TN, QUANTITY 108,351 DISTRIBUTION Nationwide and PR REASON Potential sub-potency at 15-month stability interval. --------------------------------------------------------------------------- Route To ____________________________________ Status ______________________ PRODUCT a) Cobe Optima XP Hollow Fiber Membrane Oxygenator/Reservoir, Sterile, (Standalone Systems) Catalog Numbers 050255500, 050316400, 050412400, 050500000 RECALL NUMBER # Z-1422-06; PRODUCT b) Cobe CML Duo Flat Sheet Membrane Oxygenator/Reservoir, sterile, (Standalone systems). Catalog Numbers: 050226400, 050422400 RECALL NUMBER # Z-1423-06; PRODUCT c) Cobe Optimin Hollow Fiber Sealed System, Oxygenator/Reservoir, Sterile, (Standalone systems), Catalog numbers:050125400, 050502000 RECALL NUMBER # Z-1424-06; PRODUCT d) Cobe Optima XP Hollow Fiber Membrane Oxygenator, Sterile, (Custom Heart/Lung Packs), Catalog Numbers: 028901008, 032794001, 067129002, 067149006, 067174002, 067188002, 067212004, 067221009, 067236004, 067260001, 067296002, 067351006, 067354002, 067388004, 067434005, 067442001, 067447010, 067452001, 067458005, 067481003, 06748002, 067523001, 067529002, 067536002, 067539005, 067570003, 067577001, 067594003, 067602001, 067614005, 067625001, 067634005, 067662002, 067668001, 067682001, 067683003, 067686005, 067694002, 067709001, 067710001, 067714001, 067721002, 067722001, 067735002, 078011601, 078011701, 078014002, 078107009, 078149017, 078183015, 078196012, 078249006, 078280017, 078346013, 078351010, 078399009, 078439012, 078522010, 078534012, 078541004, 078549011, 078574008, 078707005, 078766004, 078892004, 078898003, 078909002, 0789337004, 078959005, 078987001, 078988002, 07896006 RECALL NUMBER # Z-1425-06; PRODUCT e) Cobe CML Duo Flat Sheet Membrane Oxygenator, sterile, (Custom Heart/Lung Packs), Catalog numbers: 067100001, 078002103, 078005802, 078159025, 078201013, 078212009, 078310006, 078332022, 078348014, 078428010, 078688007, 078869003 RECALL NUMBER # Z- 1426-06; PRODUCT f) Cobe Optimin Hollow Fiber Sealed System, Sterile, (Custom Heart/Lung Pack), Catalog Numbers: 067350004, 067734001, 067736002 RECALL NUMBER # Z-1427-06; PRODUCT g) Cobe Optima XP Hollow Fiber Membrane Oxygenator, Non-Sterile, Catalog Number 436422974, (shipped International only for use in Heart/Lung packs) RECALL NUMBER # Z-1428-06; PRODUCT h) Cobe CML Duo Flat Sheet Membrane Oxygenator, Non-sterile, Catalog Number: 436122974, (shipped international only for use in Heart/Lung Packs) RECALL NUMBER # Z-1429-06. CODE a) Lot Numbers 0608000009, 0610800078, 0613600057; Lot Numbers 0607300017, 0608000011, 0608700110, 0608800063, 0609400137, 0610100174, 0610200062, 0610800080, 0611600081, 0612200144, 0612900020, 0612900039, 0613600059; Lot Numbers 0608000010, 0608700109, 0609400136, 0610800079, 0611600080, 0612200143, 0612900038, 0613000001; Lot Number 0609400138, 0610100176, 0611600082, 0612200146; b) Lot Numbers: 0607300026, 0609400146, 0610100183, 0611600089, 0612200155, 0612900044, Lot Numbers: 0607300025, 0608000018, 0608700122, 0610800088; c) Lot Numbers: 0610800081, 0613600060, 0614400061, Lot number 0612200145; d) Serial numbers: 0609400012, 0609400029, 0611500069, 0611500082, 0612800162, 0614300012, 0614300033, 0610800032, 0612800057, 0613600155, 0611500073, 0614300014, 0612200082, 0612200097, 0613600017, 0611500011, 0612800111, 0611500037, 0613500120, 0615000130, 0610100013, 0610100022, 0610100023, 0611500012, 0611500022, 0611500023, 0611500024, 0611500074, 0613600044, 0611600153, 0614200056, 0610100063, 0612800086, 0615000047, 0615000057, 0612200035, 0610100082, 0611500014, 0613500121, 0614300045, 0612200011, 0613500075, 0613500076, 0615000049, 0611500099, 0613500097, 0613500104, 0614300067, 0612800142, 0612200058, 0615200006, 0612400011, 0611500038, 0612200012, 0614200088, 0612200059, 0614300017, 0611500015, 0615000099, 0612200036, 0610800019, 0615000133, 0612800143, 0615000051, 0612200061, 0615000100, 0613600046, 0614300068, 0612200038, 0613800007, 0614300001, 0610100084, 0614300018, 0612200014, 0612200126, 0612800089, 0615000073, 0612800168, 0610900041, 0613100004, 0610900044, 0612800090, 0613600021, 0610800116, 0612200084, 0615000074, 0612200016, 0612800144, 0611500100, 0612800145, 0611500039, 0612800068, 0612400007, 0614200090, 0609400054, 0610100042, 0611500040, 0613600022, 0610800048, 0610800117, 0612200086, 0613600023, 0609400055, 0611500041, 0612800091, 0615000052, 0609400129, 0610100103, 0610700029, 0608900036, 0608900037, 0615200007, 0612900006, 0610100104, 0613800003, 0614300046, 0609400057, 0609400167, 0611500076, 0609400058, 0613600025, 0615000075, 0612200017, 0610100085, 0610100043, 0611600119, 0610100087, 0614300021, 0609400093, 0612200064, 0610800118, 0614300022, 0609400059, 0611500118, 0610100067, 0610100071, 0613100005, 0613100006, 0608700021, 0610100088, 0612800115, 0612200042, 0612200049, 0612200019, 0614300072; e) Serial numbers: 0614200085, 0610800149, 0612800146, 0614200089, 0610800022, 0612800069, 0614300069, 0609400089, 0609400102, 0609400103, 0610800049, 0612800114, 0612800125, 0612800126, 0609400091, 0614200058, 0614200069, 0610800151, 0614300071, 0609400130, 0611500101, 0614200059, 0613500077, 0613500083, 0612200040, 0614200060, 0612200063, 0614300020, 0612800074, 0610100066, 0612200065; f) Lot Numbers: 0610100039, 0612800087, 0615000071; Lot Number 0614400151; Lot numbers: 0608700018, 0612200085; g) Lot number 0610800082; h) Lot numbers: 0611600091, 0613600069. MANUFACTURER Senior Operations, Inc., Bartlett, IL. RECALLED BY COBE Cardiovascular, Inc, Arvada, CO QUANTITY 9,053 units DISTRIBUTION Nationwide and Internationally REASON Cooling and rewarming time is extended. Efficiency of the heat exchangers is reduced because many of the folds that are critical to heat exchange on the blood side of the units were blocked with a metallic material, thus decreasing the surface area needed for proper heat transfer. ---------------------------------------------------------------------------  1