CA, NY, VA, TN, OK, OH, NC, MN, MI. LA, KS, IN, FL, and AR
6) Fair Oaks Farms Fine Cheese, Sweet Swiss, clear plastic package, ~ 0.5 lbs. Recall # F-0463-2012;
CA, CO, IA, ID, IN, KS, MI, MO, OR, SD, TX, WA, WI and WY
1) Cranberry Apricot Nut Crostini has a 9 oz (225 g) net weight. The UPC is 8 91886 00322 9. The product is labeled in part: “***MACRINA BAKERY***cranberry apricot nut crostini***Unbleached white wheat flour, natural sour starter, filtered water, dried unsulphured apricots, cranberries, pecans, walnuts, organic wheat flour, salt, anise, cloves, olive oil, garlic, contains wheat***”. Recall # F-0486-2012;
2) Herb Wheat Walnut Crostini has a 9 oz (225 g) net weight. The UPC is 8 91886 00321 2. The product is labeled in part: “***MACRINA Bakery Cafe***HERB WHEAT WALNUT CROSTINI***Unbleached white wheat flour, natural sour starter, filtered water, walnuts, organic whole wheat flour, assorted fresh herbs (parsley, thyme, rosemary, sage, oregano), olive oil, garlic, contains wheat***”. Recall # F-0487-2012
Assorted Mexican Pastries and Cookies with red frosting and/or gel. Product is sold under brand name Panaderia El Angel. Pastries are distributed in bulk on a metal tray wrapped with cellophane. Each tray contains 50 units total but 4 units contain and are observed with a red-pink color frosting and 3 units are observed with a red-pink color filling gel. Trays are distributed to consignees without an affixed label. A label is provided to the consignee separately and then it is placed on the bakery display case. There is no net quantity nor UPC on the label. The product is labeled in parts: “***Wheat flour bleached & unbleached granulated, Vegetable bakes margarine (non-dairy), all purpose shortening, partially hydrogenated soybean oil, sugar, water, salt, margarine (partially hydrogenated), vegetable shortening***, eggs, 2% milk, butter, soy bean oils, yeast, melted barley flour***Yellow (5), Yellow (6) Citric Acid, ***artificially colored with beta-carotene. Recall # F-0491-2012
1) Ondansetron Hydrochloride Tablets, 4 mg, 1 Card x 3 Tablets per carton, Rx only, Manufactured in Israel By: Teva Pharmaceutical IND. Ltd., Jerusalem, 91010, Israel; Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-0233-33.
2) Ondansetron Hydrochloride Tablets, 8 mg, 1 Card x 3 Tablets per carton, Rx only, Manufactured in Israel by: Teva Pharmaceutical IND. Ltd., Jerusalem, 91010, Israel; Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-7236-33.
Nationwide, Canada, Saudi Arabia, Egypt, United Kingdom, France, Germany, Greece, Italy, Bosnia Herzegovina, Austria, Netherlands, Korea, Spain, China, India, Japan, Mexico, Philippines, and Taiwan
Last Four Digits of Lot #2408, 2064, 2851, 2076, 2081, 2804, 2109, 2100, 2519, 2521, 2008, 3063, 2537, 2350, 2382, 2834, 3030, 3043, 3250, 3194, 2105, 2938, 2063, 2148, 2187, 2313, 2324, 2330, 2331, 2424, 2284, 2692, 2067, 2416, 2802, 3294, 2846, 2852, 2901, 3011, 3075, 3167, 2590, 2591, 2462, 3044, 2305, 3155, 3066, 3102, 3290, 3188, 2176, 2781, 3293, 2117, 3308, 3309, 2862, 2321, 2225, 2235, 2238, 3041, 7003, 7004, 2502, 2599, 3317, 2246, 2272, 2217, 3330, 3048, 2954, 3341, 2391, 2835, 2557, 2303, 2294, 2440, 2348, 2597, 3003, 2369, 2500, 2070, 2613, 2299, 2301, 2216, 3146, 3166, 3110, 2262, 2040, 2675, 3064, 2097, 2145, 3203, 2870, 2306, 2750, 2776, 2691, 2410, 7005, 2930, 2494, 2052, 2244, 2245, 2457, 3345, 2683, 2152, 2995, 2970, 2816, 2763, 2593, 2708, 2674, 2744, 2547, 2966, 2967, 2730, 2836, 2843, 2844, 2845, 2643, 2751, 2261, 2373, 2697, 2559, 2405, 2565, 3189, 2121, 3134, 2821, 3195, 2157, 2158, 2206, 3193, 3285, 3350, 2841, 2401, 2503, 2863, 2534, 2140, 2530, 3355, 3262, 3307, 2581, 2736, 2982, 2418, 2280, 2281, 3149, 2353, 2456, 2346, 2349, 2091, 2343, 3213, 2815, 2857, 2909, 2973, 3049, 3047, 2544, 2688, 3060, 2315, 2308, 2676, 2961, 3176, 2760, 3187, 2267, 2504, 2908, 2738, 2007, 3156, 3373, 3380, 2354, 2524, 2190, 2250, 3173, 3197, 3349, 2470, 2178, 2174, 2785, 3022, 3371, 3108, 2394, 3352, 2383, 2824, 2574, 2659, 2789, 2782, 2788, 2498, 2614, 2975, 2398, 3150, 2620, 2752, 3319, 2445, 2501, 2837, 2737, 2801, 2194, 2213, 2513, 2558, 2957, 2984, 2204, 3123, 2395, 2478, 2595, 2921, 3325, 2399, 3074, 3087, 3181, 2900, 2538, 3314, 2082, 3236, 2814, 2095, 3200, 3055, 3056, 2022, 3178, 2310, 3093, 2198, 2096, 2268, 3305, 2952, 2628, 2994, 2427, 2655, 2989, 2374, 2447, 3378, 3198, 3346, 2362, 2455, 2721, 3261, 2423, 2439, 2569, 2682, 3177, 3233, 2104, 2871, 2876, 2073, 2316, 2128, 3336, 3427
LATITUDE Patient Management System, Models 6441*, 6442*, 6465*, 6488 (USA). There are two software applications: the programmer software and the LATITUDE remote monitoring system software. The Model 2868 Software Application is loaded onto the Model 3120 programmers. These programmers are used during in-office follow-ups. The software version affected domestically is version 1.05 for COGNIS and TELIGEN and internationally is version 2.04 for COGNIS, TELIGEN, and PUNCTUA, ENERGEN, and INCEPTA. The PUNCTUA, ENERGEN, and INCEPTA are not currently approved in the US. The LATITUDE Patient Management system is intended for use to remotely communicate with a compatible Guidant or Boston Scientific pulse generator and transfer data to a central database. The LATITUDE Patient Management System software is web-based and therefore at any point in time, there is only one (1) released version for each model number. The current version is 7.1. Both the programmer software and the LATITUDE remote monitoring system software similarly display the shock lead impedance measurements. Recall # Z-0333-2012
Units: G30369, G29103, G34727, G32313, G30367, G29101, G31330, G34401, G32304, G30962, G30610, G30668, G29986, G28427, G28581, G28673, G28430, G28755, G28576, G28574, G28676, G28678, G28811, G28763, G28806, G28863, G28809, G28864, G28936, G29035, G29042, G30720, G28929, G29043, G29102, G28421, G29296, G29299, G29843, G31188, G29832, G29838, G29844, G29840, G29983, G30300, G30027, G29980, G30210, G30213, G30034, G30208, G30309, G30310, G30530, G30533, G30558, G30565, G32986, G30606, G30611, G30961, G30718, G30662, G30717, G31397, G31326, G31186, G31190, G31323, G29842, G34393, G31404, G31512, G31522, G31518, G31515, G31517, G30073, G32359, G32363, G32305, G32364, G32366, G32385, G32425, G32389, G32501, G32680, G32682, G32809, G32814, G34285, G32905, G32820, G32821, G32824, G32904, G32908, G33335, G33339, G33338, G33428, G33433, G34150, G34288, G34151, G34159, G34290, G34348, G34347, G34350, G34397, G34501, G34684, G34502, G34505, G34689, G30974, G34691, G34980, G34983, G34726
Lot numbers: 549490, 563542, 563543, 564885, 564886, 570133, 571504, 573502, 581088, 581439, and 582520.
SoftLab used with SA INST 4.0.2.0 to 4.0.2.51, 4.0.3.0 to 4.0.3.13, 4.5.0.0 to 4.5.0.9, 4.5.2.0 to 4.5.2.8 and SA INST 3.1.3.0 to 3.1.3.29, 3.1.6.0 to 3.1.6.17, 4.0.0.0, 4.0.1.0 to 4.0.1.32. SoftLab is a laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained, and experienced personnel. SoftLab enables the user to handle data-processing and laboratory activities, for the purpose of storing, managing, querying, and reporting laboratory data. Recall # Z-0444-2012
Source Article from http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm285341.htm
