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U.S. Department of Health and Human Services

Enforcement Report - Week of May 20, 2015

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Food Cambridge House Balmoral Thinly Sliced Exceptional Ready to Enjoy Smoked Salmon Keep Refrigerated at 38 or below Ingredients Atlantic Salmon, Salt, Sugar, and Oakwood Smoke Produced By: The Santa Barbara Smokehouse 312 N. Nopal Santa Barbara, CA 93103 www.sbsmokehouse.com Coastal Harbor by The Santa Barbara Smokehouse Smoked Atlantic Salmon Keep Refrigerated at 38 or below Ingredients Atlantic Salmon, Salt, Sugar, and Oakwood Smoke Produced By: The Santa Barbara Smokehouse 312 N. Nopal Santa Barbara, CA 93103 www.sbsmokehouse.com Products are distributed either refrigerated or frozen. All products are packaged in reduced oxygen packaging (ROP). Net weight appears to vary per package. Products are priced per weight. Batch Numbers: 8589 and 6549 6549 August 18 2014 Use By 09-16-14 8589 September 18/19 2014 Use By 09-15-15 Products that are frozen have a more extended shelf-life/use by date. Class I The firm was notified by two customers of two lot/batch numbers testing positive for Listeria monocytogenes which is an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea. Listeria infection can also cause miscarriages and stillbirths among pregnant women. The Santa Barbara Smokehouse, Inc.
Biologics Red Blood Cells Leukocytes Reduced W12871418490 Class II Blood products, collected from a donor who tested reactive for anti-HBc on two separate occasions, were distributed. Delta Blood Bank
Biologics Cryoprecipitated AHF W128714180935, W128714180600, W128714180171, W128713182311 Class II Blood products, collected from a donor who tested reactive for anti-HBc on two separate occasions, were distributed. Delta Blood Bank
Food Aleia's Parmesan Croutons, Gluten Free, NET WT 8 oz (226.8g). UPC Code: 8 55930 00162 3, Product is packaged in a brown cardboard box with white text. Lot Numbers: 410221, 413121, 416021, 417221, 419221, 510110, 514210 Class III Product manufactured with cumin that may contain peanut protein. Aleias Gluten Free Foods LLC
Food Aleia's Classic Croutons, Gluten Free, NET WT 8 oz (226.8g). UPC Code: 8 55930 00161 6, Product is packaged in a brown cardboard box with white text. Lot Numbers: 410221, 413121, 416021, 417221, 419221, 510110, 514210 Class III Product manufactured with cumin that may contain peanut protein. Aleias Gluten Free Foods LLC
Food Guacamole Dip Net Wt. 8 OZ. (.5LB) Distributed By: Whole Foods Market UPC/PLU: 0-36406-30279-0; WFM Dip Guacamole PPK UPC/PLU: 3640630278; Guacamole Bulk CC UPC/PLU: 27013500000 in plastic container All Sell by dates through 2/10/15; Bulk product Sold from food bars thru 2/5 Class II Undeclared peanut protein in products containing cumin Whole Foods Market
Food Slaw Kale Avocado HSH 14 oz. UPC/PLU code: 0-00000-68899 Best By: 2/9/2015 Class II Undeclared peanut protein in products containing cumin Whole Foods Market
Food Tofu Grilled Lime Chipotle UPC/PLU code: 2-31090-00000 Best By: 2/9/2015 Class II Undeclared peanut protein in products containing cumin Whole Foods Market
Food Burrito Chipotle Lime Tofu UPC/PLU: 2-65293-00000; Burrito Chipotle Lime Tofu Tacos UPC/PLU: 2-83938-00000 Best By: 2/7/2015 Class II Undeclared peanut protein in products containing cumin Whole Foods Market
Food Taco Salad Tofu Chipotle Lime UPC/PLU: 2-65294-00000 Best By: 2/7/2015 Class II Undeclared peanut protein in products containing cumin Whole Foods Market
Food Salsa Fresca Net Wt. 8 oz. (.5LB) Whole Foods Market; WFM Salsa Fresca PPK; UPC/PLU: 3640630306; Salsa Fresca Bulk CC UPC/PLU: 26206400000 All Sell by dates through 2/10/15; bulk products: Sold from food bars thru 2/5 Class II Undeclared peanut protein in products containing cumin Whole Foods Market
Food Pico De Gallo Salsa Net Wt. 8 oz. (.5LB); WFM Dip Salsa Pico De Gallo PPK UPC/PLU: 3640630279; Salsa Pico de Gallo Bulk UPC/PLU: 26890500000 All Sell by dates through 2/10/15; bulk: Sold from food bars thru 2/5 Class II Undeclared peanut protein in products containing cumin Whole Foods Market
Food Adobo Enchiladas & Dirty Rice Net Wt. 48 OZ. (3LB) (1.36kg) Whole Foods Market Kitchens UPC/PLU: 036406302561; Enchilada Adobo Bulk UPC/PLU: 26978700000 All Sell by dates through 2/10/15; bulk: Sold from food bars thru 2/5 Class II Undeclared peanut protein in products containing cumin Whole Foods Market
Food Mediterranean Mezze Snack Pack Net Wt. 9.5 OZ (268g) Whole Foods Market Kitchens UPC/PLU 036406304329 All Sell by dates through 2/10/15 Class II Undeclared peanut protein in products containing cumin Whole Foods Market
Food Whole Foods Market Vegetarian Firehouse Chili Net Wt. 24 oz. (1.5LB/680g) Whole Foods Market Kitchens UPC/PLU: 036406303940 All Sell by dates through 2/10/15 Class II Undeclared peanut protein in products containing cumin Whole Foods Market
Food Quesadilla Mushroom Goat Cheese UPC/PLU: 26405800000 Sold from food bars thru 2/5 Class II Undeclared peanut protein in products containing cumin Whole Foods Market
Food Quesadilla Veggie UPC/PLU: 26404400000 Sold from food bars thru 2/5 Class II Undeclared peanut protein in products containing cumin Whole Foods Market
Food Burrito Black Bean and Cheese UPC/PLU: 26270400000 Sold from food bars thru 2/5 Class II Undeclared peanut protein in products containing cumin Whole Foods Market
Food Red Beans and Rice UPC/PLU: 26193100000 Sold from food bars thru 2/5 Class II Undeclared peanut protein in products containing cumin Whole Foods Market
Food Rub Latin Spice 5 LB. UPC/PLU: 48000006317 Sold from food bars thru 2/5 Class II Undeclared peanut protein in products containing cumin Whole Foods Market
Food Rub BBQ Dry 5LB UPC/PLU: 48000024279 Sold from food bars thru 2/5 Class II Undeclared peanut protein in products containing cumin Whole Foods Market
Food Marinade Lime Chipotle 2 Gallon UPC/PLU: 48000024264; Marinade Lime Chipotle UPC/PLU: 48000024272 Sold from food bars thru 2/5 Class II Undeclared peanut protein in products containing cumin Whole Foods Market
Food Chipotle Adobo UPC/PLU: 48000024753 Sold from food bars thru 2/5 Class II Undeclared peanut protein in products containing cumin Whole Foods Market
Food Chili Firehouse HSH UPC/PLU: 48000035037 Sold from food bars thru 2/5 Class II Undeclared peanut protein in products containing cumin Whole Foods Market
Food Salsa Verde UPC/PLU: 48000011104 Sold from food bars thru 2/5 Class II Undeclared peanut protein in products containing cumin Whole Foods Market
Food Southwest Stuffed Sweets HSH CC UPC/PLU: 28634600000; Southwest Stuffed Sweets HSH FP UPC/PLU: 26066400000 Best By: 2/10/2015 Class II Undeclared peanut protein in products containing cumin Whole Foods Market
Food Ceviche, Mushroom UPC/PLU: 26831100000 Best By: 2/6/2015 Class II Undeclared peanut protein in products containing cumin Whole Foods Market
Food Burger, Lentil Dal UPC/PLU: 26157400000 Use by 1/20/15-2/7/15 Class II Undeclared peanut protein in products containing cumin Whole Foods Market
Food Burrito, Black Bean UPC/PLU: 00000480430 Use by 2/8/15-2/11/15 Class II Undeclared peanut protein in products containing cumin Whole Foods Market
Food Burrito, Shrimp UPC/PLU: 00000480432 Use by 2/8/15-2/11/15 Class II Undeclared peanut protein in products containing cumin Whole Foods Market
Food Dip, Black Bean UPC/PLU: 00000484003 Use by 1/20/15-2/7/15 Class I Undeclared peanut protein in products containing cumin Whole Foods Market
Food Dip, Mexican Layer Large UPC/PLU: 00000480504; Dip, Mexican Layer Small UPC/PLU: 00000480505 Use by 1/20/15-2/7/15 Class II Undeclared peanut protein in products containing cumin Whole Foods Market
Food Enchilada, Adobo Black Bean UPC/PLU: 26735600000 Use by 2/8/15-2/11/15 Class I Undeclared peanut protein in products containing cumin Whole Foods Market
Food HotBar, NE Tofu Meatloaf UPC/PLU: 48000088750 Use by 1/20/15-1/25/15 Class II Undeclared peanut protein in products containing cumin Whole Foods Market
Food HotBar, Latin Comfort, Stewed Black Beans UPC/PLU: 48000088655 Use by 2/27/15 Class I Undeclared peanut protein in products containing cumin Whole Foods Market
Food Meatloaf, Tofu Use by 1/20/15-2/7/15 Class II Undeclared peanut protein in products containing cumin Whole Foods Market
Food Quesadilla, Black Bean Use by 2/8/15-2/11/15 Class II Undeclared peanut protein in products containing cumin Whole Foods Market
Food Quesadilla, Vegan Beef UPC/PLU: 27267700000 Use by 1/20/15-2/7/15 Class I Undeclared peanut protein in products containing cumin Whole Foods Market
Food Salad, Bowl, Mediterranean UPC/PLU: 00000480502 Use by 1/20/15-2/7/15 Class II Undeclared peanut protein in products containing cumin Whole Foods Market
Food Salad, Papas con Remolachas UPC/PLU: 48000086479 Use by 1/20/15-2/1/15 Class II Undeclared peanut protein in products containing cumin Whole Foods Market
Food Sauce, Adobo UPC/PLU: 48000011103 Use by 7/25/15 Class II Undeclared peanut protein in products containing cumin Whole Foods Market
Food Vegetarian, NEW Falafel UPC/PLU: 48000025248 Use by 1/20/15-2/7/15 Class I Undeclared peanut protein in products containing cumin Whole Foods Market
Food Soup, Moroccan Green Lentil Cups Use by 3/4/15-3/22/15 Class II Undeclared peanut protein in products containing cumin Whole Foods Market
Food Quesadilla Adobo Black Bean Use by 2/8/15-2/11/15 Class II Undeclared peanut protein in products containing cumin Whole Foods Market
Drugs MAGNESIUM SULFATE IN 5% DEXTROSE INJECTION, USP, 10 mg/mL; 100 mL bag, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-6727-23, UPC (01) 0 030409 672723 1. Lot: 42-120-JT, Exp 01DEC2015 Class I Labeling: Wrong Bar Code: There is a potential for some units to be mislabeled with an incorrect barcode on the immediate container that scans as heparin sodium 2000 USP units/1000 mL in 0.9% in sodium chloride injection. Hospira Inc.
Drugs 17-HP Hydroxyprogesterone 250mg/1ml Injection, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155 All lots Class II Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection due to observations associated with certain quality control procedures that present a risk to sterility and quality assurance. Health Innovations Pharmacy, Inc
Drugs HCG 1000 Units/mL Injection, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155 All lots Class II Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection due to observations associated with certain quality control procedures that present a risk to sterility and quality assurance. Health Innovations Pharmacy, Inc
Drugs Cyanocobalamin 2000mcg/1ml Injection, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155 All lots Class II Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection due to observations associated with certain quality control procedures that present a risk to sterility and quality assurance. Health Innovations Pharmacy, Inc
Drugs Methylcobalamin 1000 mcg/mL Injection, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155 All lots Class II Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection due to observations associated with certain quality control procedures that present a risk to sterility and quality assurance. Health Innovations Pharmacy, Inc
Drugs Sodium Tetradecyl 1% Injection, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155 All lots Class II Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection due to observations associated with certain quality control procedures that present a risk to sterility and quality assurance. Health Innovations Pharmacy, Inc
Drugs Laureth-P 1% Injection (Polidocanol), Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155 All lots Class II Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection due to observations associated with certain quality control procedures that present a risk to sterility and quality assurance. Health Innovations Pharmacy, Inc
Drugs Trimix #1 (Original) Injection (papaverine 75 mg - phentolamine 2.5 mg - PGE 25 mcg/10 mL), Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155 All lots Class II Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection due to observations associated with certain quality control procedures that present a risk to sterility and quality assurance. Health Innovations Pharmacy, Inc
Drugs Dexamethasone 4 mg/mL Iontophoresis, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155 All lots Class II Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection due to observations associated with certain quality control procedures that present a risk to sterility and quality assurance. Health Innovations Pharmacy, Inc
Drugs Fortifed Tobramycin 15 mg/1 mL Opth., Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155 All lots Class II Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection due to observations associated with certain quality control procedures that present a risk to sterility and quality assurance. Health Innovations Pharmacy, Inc
Drugs Glycerin 98.5% Opth. Solution, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155 All lots Class II Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection due to observations associated with certain quality control procedures that present a risk to sterility and quality assurance. Health Innovations Pharmacy, Inc
Drugs EDTA 3% Eye Drops, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155 All lots Class II Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection due to observations associated with certain quality control procedures that present a risk to sterility and quality assurance. Health Innovations Pharmacy, Inc
Drugs Serum 50% BSS 50% Opth Drops, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155 All lots Class II Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection due to observations associated with certain quality control procedures that present a risk to sterility and quality assurance. Health Innovations Pharmacy, Inc
Drugs Phospholine Iodide 0.03% Opth Drops, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155 All lots Class II Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection due to observations associated with certain quality control procedures that present a risk to sterility and quality assurance. Health Innovations Pharmacy, Inc
Drugs Progest 200 mg/1 mL Cream, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155 All lots Class II Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection due to observations associated with certain quality control procedures that present a risk to sterility and quality assurance. Health Innovations Pharmacy, Inc
Drugs Testosterone 100 mg/1 mL Injection, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155 All lots Class II Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection due to observations associated with certain quality control procedures that present a risk to sterility and quality assurance. Health Innovations Pharmacy, Inc
Drugs Estradiol 0.01% Vaginal Cream, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155 All lots Class II Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection due to observations associated with certain quality control procedures that present a risk to sterility and quality assurance. Health Innovations Pharmacy, Inc
Drugs Estriol 5% Cream Vaginal Cream, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155 All lots Class II Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection due to observations associated with certain quality control procedures that present a risk to sterility and quality assurance. Health Innovations Pharmacy, Inc
Drugs Naltrexone 4.5 mg Caps, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155 All lots Class II Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection due to observations associated with certain quality control procedures that present a risk to sterility and quality assurance. Health Innovations Pharmacy, Inc
Drugs Ibuprofen 10% cream, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155 All lots Class II Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection due to observations associated with certain quality control procedures that present a risk to sterility and quality assurance. Health Innovations Pharmacy, Inc
Drugs Acetylcysteine 10% Opth Solution, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155 All lots Class II Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection due to observations associated with certain quality control procedures that present a risk to sterility and quality assurance. Health Innovations Pharmacy, Inc
Drugs Voriconazole 1% Opth Drops, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155 All lots Class II Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection due to observations associated with certain quality control procedures that present a risk to sterility and quality assurance. Health Innovations Pharmacy, Inc
Drugs DHEA 10 mg SR Caps, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155 All lots Class II Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection due to observations associated with certain quality control procedures that present a risk to sterility and quality assurance. Health Innovations Pharmacy, Inc
Drugs Pregnenolone 20 mg SR Capsule, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155 All lots Class II Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection due to observations associated with certain quality control procedures that present a risk to sterility and quality assurance. Health Innovations Pharmacy, Inc
Drugs BLT New Formula 20%/7%/7% Sample, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155 All lots Class II Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection due to observations associated with certain quality control procedures that present a risk to sterility and quality assurance. Health Innovations Pharmacy, Inc
Drugs Keto 10%-Gabap 10%-Ketamine 2% Cream, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155 All lots Class II Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection due to observations associated with certain quality control procedures that present a risk to sterility and quality assurance. Health Innovations Pharmacy, Inc
Drugs Boric Acid Vaginal Capsules, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155 All lots Class II Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection due to observations associated with certain quality control procedures that present a risk to sterility and quality assurance. Health Innovations Pharmacy, Inc
Drugs Baclofen 20 mg/4 mL Susp., Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155 All lots Class II Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection due to observations associated with certain quality control procedures that present a risk to sterility and quality assurance. Health Innovations Pharmacy, Inc
Drugs T4 66mcg - T3 10mcg SR Capsule, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155 All lots Class II Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection due to observations associated with certain quality control procedures that present a risk to sterility and quality assurance. Health Innovations Pharmacy, Inc
Drugs Promethazine 25 mg/0.5 mLGel, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155 All lots Class II Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection due to observations associated with certain quality control procedures that present a risk to sterility and quality assurance. Health Innovations Pharmacy, Inc
Drugs Leucovorin 1 mg/1 mL Susp, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155 All lots Class II Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection due to observations associated with certain quality control procedures that present a risk to sterility and quality assurance. Health Innovations Pharmacy, Inc
Drugs Diclo 3% - Bacl 2% - Cyclo 2% - Lidoc 2% Cream, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155 All lots Class II Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection due to observations associated with certain quality control procedures that present a risk to sterility and quality assurance. Health Innovations Pharmacy, Inc
Drugs Warfarin 2.5 ng Lactose Free Caps, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155 All lots Class II Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection due to observations associated with certain quality control procedures that present a risk to sterility and quality assurance. Health Innovations Pharmacy, Inc
Drugs Nitroglycerin 0.2% Compd Cream, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155 All lots Class II Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection due to observations associated with certain quality control procedures that present a risk to sterility and quality assurance. Health Innovations Pharmacy, Inc
Drugs Spironolactone 5 mg/mL Susp, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155 All lots Class II Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection due to observations associated with certain quality control procedures that present a risk to sterility and quality assurance. Health Innovations Pharmacy, Inc
Drugs Carvedilol 1.25 mg/mL, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155 All lots Class II Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection due to observations associated with certain quality control procedures that present a risk to sterility and quality assurance. Health Innovations Pharmacy, Inc
Drugs Pyrimethamine 2 mg/1 mL Susp, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155 All lots Class II Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection due to observations associated with certain quality control procedures that present a risk to sterility and quality assurance. Health Innovations Pharmacy, Inc
Drugs Nortriptyline 10 mg/5 mL Susp, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155 All lots Class II Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection due to observations associated with certain quality control procedures that present a risk to sterility and quality assurance. Health Innovations Pharmacy, Inc
Drugs Nadolol 10 mg/1 mL Susp, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155 All lots Class II Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection due to observations associated with certain quality control procedures that present a risk to sterility and quality assurance. Health Innovations Pharmacy, Inc
Drugs Levodopa 250 mg NSR Capsules,Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155 All lots Class II Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection due to observations associated with certain quality control procedures that present a risk to sterility and quality assurance. Health Innovations Pharmacy, Inc
Drugs Glycopyrrolate 0.2 mg/1 mL Susp (Robinul), Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155 All lots Class II Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection due to observations associated with certain quality control procedures that present a risk to sterility and quality assurance. Health Innovations Pharmacy, Inc
Drugs Rifampin 25 mg/1 mL Susp, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155 All lots Class II Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection due to observations associated with certain quality control procedures that present a risk to sterility and quality assurance. Health Innovations Pharmacy, Inc
Drugs Nexium 2 mg/1 mL Solution, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155 All lots Class II Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection due to observations associated with certain quality control procedures that present a risk to sterility and quality assurance. Health Innovations Pharmacy, Inc
Drugs Azithromycin 100 mg Rectal Suppository, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155 All lots Class II Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection due to observations associated with certain quality control procedures that present a risk to sterility and quality assurance. Health Innovations Pharmacy, Inc
Drugs Hydroquinone 10% Cream, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155 All lots Class II Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection due to observations associated with certain quality control procedures that present a risk to sterility and quality assurance. Health Innovations Pharmacy, Inc
Drugs Fortified Vancomycin 25 mg/1 mL Opth Drops, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155 All lots Class II Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection due to observations associated with certain quality control procedures that present a risk to sterility and quality assurance. Health Innovations Pharmacy, Inc
Drugs Folic Acid 2 mg/1 mL Susp, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155 All lots Class II Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection due to observations associated with certain quality control procedures that present a risk to sterility and quality assurance. Health Innovations Pharmacy, Inc
Drugs Pyridoxine 100 mg/1 mL Syrup, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155 All lots Class II Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection due to observations associated with certain quality control procedures that present a risk to sterility and quality assurance. Health Innovations Pharmacy, Inc
Drugs Nifedipine 0.2% - Lidocaine 2% Jelly, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155 All lots Class II Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection due to observations associated with certain quality control procedures that present a risk to sterility and quality assurance. Health Innovations Pharmacy, Inc
Drugs Renacidin Irrigation Solution, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155 All lots Class II Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection due to observations associated with certain quality control procedures that present a risk to sterility and quality assurance. Health Innovations Pharmacy, Inc
Drugs Hydroxyurea 100 mg/1 mL Susp, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155 All lots Class II Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection due to observations associated with certain quality control procedures that present a risk to sterility and quality assurance. Health Innovations Pharmacy, Inc
Drugs Phenylephrine 0.5% Solution (Bottle), Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155 All lots Class II Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection due to observations associated with certain quality control procedures that present a risk to sterility and quality assurance. Health Innovations Pharmacy, Inc
Drugs Verapamil HCl 15% Topical Cream, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155 All lots Class II Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection due to observations associated with certain quality control procedures that present a risk to sterility and quality assurance. Health Innovations Pharmacy, Inc
Drugs Sildenafil 10 mg/1 mL Susp, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155 All lots Class II Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection due to observations associated with certain quality control procedures that present a risk to sterility and quality assurance. Health Innovations Pharmacy, Inc
Drugs Ciprodex with Amphoteracin B (ear drops), Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155 All lots Class II Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection due to observations associated with certain quality control procedures that present a risk to sterility and quality assurance. Health Innovations Pharmacy, Inc
Drugs DNCB 0.3% Ointment, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155 All lots Class II Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection due to observations associated with certain quality control procedures that present a risk to sterility and quality assurance. Health Innovations Pharmacy, Inc
Drugs Methenamine/Phenyl Salicylate Capsule, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155 All lots Class II Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection due to observations associated with certain quality control procedures that present a risk to sterility and quality assurance. Health Innovations Pharmacy, Inc
Drugs Thymol 2% Solution, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155 All lots Class II Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection due to observations associated with certain quality control procedures that present a risk to sterility and quality assurance. Health Innovations Pharmacy, Inc
Drugs Lansoprazole 3 mg/mL Susp, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155 All lots Class II Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection due to observations associated with certain quality control procedures that present a risk to sterility and quality assurance. Health Innovations Pharmacy, Inc
Drugs Colchicine 0.6 mg Caps, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155 All lots Class II Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection due to observations associated with certain quality control procedures that present a risk to sterility and quality assurance. Health Innovations Pharmacy, Inc
Drugs Triest 5 mg - Progest 150 mg Capsule, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155 All lots Class II Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection due to observations associated with certain quality control procedures that present a risk to sterility and quality assurance. Health Innovations Pharmacy, Inc
Drugs Cyclandelate 200 mg Caps, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155 All lots Class II Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection due to observations associated with certain quality control procedures that present a risk to sterility and quality assurance. Health Innovations Pharmacy, Inc
Drugs Coconut Oil Suppository, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155 All lots Class II Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection due to observations associated with certain quality control procedures that present a risk to sterility and quality assurance. Health Innovations Pharmacy, Inc
Drugs Nystatin 50,000 Units Suppository, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155 All lots Class II Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection due to observations associated with certain quality control procedures that present a risk to sterility and quality assurance. Health Innovations Pharmacy, Inc
Drugs Hydrocortisone 1.6 mg/0.5 mL Susp, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155 All lots Class II Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection due to observations associated with certain quality control procedures that present a risk to sterility and quality assurance. Health Innovations Pharmacy, Inc
Drugs Phen 15 mg - Topri 92 mg SR Cap (Qsymia), Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155 All lots Class II Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection due to observations associated with certain quality control procedures that present a risk to sterility and quality assurance. Health Innovations Pharmacy, Inc
Devices ThermoFlo 1 HME, Disposable, Non-sterile, Expiry date 04/17. Used as a humidifier in a breathing circuit. Product code: 6160, Batch number: 110208-50 Class III Outer shipping carton was marked with an incorrect expiry date, however inner product carton was labeled correctly. Arc Medical Inc
Biologics Plasma Frozen Cryoprecipitated Reduced W200313074316; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. The American National Red Cross - Southern Region
Biologics Cryoprecipitated AHF W200313074316; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. The American National Red Cross - Southern Region
Drugs SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP,200 mg/ 40 mg per 5mL, CHERRY FLAVOR, 16 fl oz (473 mL) bottles (NDC 50383-0823-16), Rx only, HI-TECH PHARMACAL CO. INC, Amityville, NY 11701 Lot # 623940, Exp. 10/2015; Lot # 624487, Exp. 11/2015; Lot # 624741, Exp. 11/2015; Lot # 625296, Exp. 1/2016 Class II Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole. Akorn, Inc.
Drugs SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP,200 mg/ 40 mg per 5mL, GRAPE FLAVOR, 16 fl oz (473 mL) bottles (NDC 50383-0824-16), Rx only, HI-TECH PHARMACAL CO. INC, Amityville, NY 11701 Lot # 618358, Exp. 11/15/2015; Lot # 618646, Exp. 11/18/2015; Lot # 618649, Exp. 11/19/2015; Lot # 618652, Exp. 11/20/2015; Lot # 618746, Exp. 11/26/2015; Lot # 618749, Exp. 11/27/2015; Lot # 618934, Exp. 12/5/2015; Lot # 618940, Exp. 12/6/2015; Lot # 618946, Exp. 12/8/2015; Lot # 621496, Exp. 5/13/2016; Lot # 621890, Exp. 6/24/2016; Lot # 622779, Exp. 7/27/2016; Lot #  ...
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Class II Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole. Akorn, Inc.
Drugs SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP 800 mg/ 160 mg per 5mL, GRAPE FLAVOR, 20 mL unit dose cup (NDC 50383-0824-20), Rx only, HI-TECH PHARMACAL CO. INC, Amityville, NY 11701 Lot # 624271, Exp. Date 10/2015 Class II Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole. Akorn, Inc.
Food Trader Joe's Nuts Raw California Walnut Pieces NET WT. 16oz. (1 LB) 454g UPC 00373685 Trader Joe's Nuts Raw California Walnut Halves & Pieces NET WT. 16 OZ (1 LB) 454g UPC 00943338 Trader Joe's Nuts Raw California Walnut Baking Pieces NET WT. 16 OZ (1 LB) 454g UPC 00519342 Trader Joe's Nuts Raw California Premium Walnut Halves NET WT. 16 OZ (1 LB) 454g UPC 00519328 Trader Joe's Organic Raw Walnut Halves & Pieces NET WT. 16 OZ (1 LB) 454g UPC 00586627 The products are packaged in clear bags with UPC Codes printed on the back. For Raw California Walnut products, the "BEST BY" dates and Lot Numbers can be found printed on the back of the packages. For the Organic Raw Walnut products, the "BEST BY" dates can be found printed on the front of the packages. Trader Joe's Nuts Raw California Walnut Pieces--16 oz. UPC: 00373685 Best By Date: 12/2015 Lot Numbers: GU4345 Trader Joes  ...
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Class I The firm is recalling Raw Walnuts because the products have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis. Trader Joes Company
Devices Kinemax Stem Extenders, 80 mm, Product Usage: Kinemax Cemented Stem Extenders are modular components designed to be mated with tibial baseplates or femoral components of the Modular Rotating Hinge (MRH), Scorpio Total Stabilizer (TS) or Duracon TS knee replacement systems. The Kinemax Cemented Stem Extenders are available in three different lengths, 40 mm (Part #6476-8-250), 80mm (Part #6476-8-260) and 155mm (Part #6476-8-270). The 40 mm cemented stem extender is not indicated for use in the MRH system; however, it is indicated for use with the Scorpio TS and Duracon TS systems (LRKS/G Rev. 2). Both the 80mm and 155mm stem extenders are indicated for use in all three systems. Catalog No. 6476-8-260, Lot code: EJPLC Class II Stryker received four customer complaints reporting that inside the box labeled part #6476-8-260 (Kinemax Stem Extenders, 80 mm) there was a different part #6476-8-250 (Kinemax Stem Extenders, 40 mm. Stryker Howmedica Osteonics Corp.
Food Walnuts: America Choice, 12 oz. Plastic Pouch, UPC: 75480779049; Aurora , 6.5 oz. Plastic Cup, UPC: 65585200097; Aurora, 14.0 oz. Plastic Tub, UPC: 65585200070; Aurora, Bulk, NO UPC; Aurora, 4.0 oz. Plastic Pouch, UPC: 65585200490; Aurora, 12.0 oz. Plastic Pouch, UPC: 65585200316; Belmont Market, 6.5 oz. Plastic Cup, UPC: 65585200097; Ernest Klein, 6.5 oz. Plastic Cup, UPC: 65585200097; Food Emporium Brand Products, 14.0 oz. Plastic Tub, UPC: 1119079096; Food Emporium Brand Products, 12.0 oz. Plastic Pouch, UPC: 72297451004; Gauls Market Brand Products, 6.5 oz. Plastic Cup, UPC: 65585200097; Giant Carlisle Food Store, 6.5 oz. Plastic Cup, UPC: 68826713594; Giant of Maryland, 6.5 oz. Plastic Cup, UPC: 68826713594; Gourmet Garage, 6.5 oz. Plastic Cup, UPC: 79084505931; Gourmet Garage, 14.0 oz. Plastic Tub , UPC: 79084505371; Harvest Co Op Market, 6.5 oz. Plastic Cup, UPC: 65585200097; Hurley Ridge, 6.5 oz. Plastic Cup, UPC: 65585200097; Hurley Ridge, 12 oz. Plastic Pouch, UPC: 65585200316; Lees Market, 6.5 oz. Plastic Cup, UPC: 65585200097; Martins Food, 6.5 oz. Plastic Cup, UPC: 68826713594; Palmers Market, 6.5 oz. Plastic Cup, UPC: 65585200097; Stop & Shop, 6.5 oz. Plastic Cup, UPC: 68826713594; Union Market, 6.5 oz. Plastic Cup, UPC: 65585200097; Walter Stewart Market, 14.0 oz. Plastic Tub, UPC: 65585200070; Wild Acorns, 6.5 oz. Plastic Cup, UPC: 81957401075; Wild By Nature Brand Products, 6.5 oz. Plastic Cup, UPC: 65585270097; Windfall Market, 6.5 oz. Plastic Cup, UPC: 65585200097 Best if used by date range: 10/29/15 12/7/15 Class I Salmonella Aurora Products, Inc.
Food 4 Section Nut Tray Assortment: Aurora 13 oz. Plastic Tray UPC: 65585200141; Food Emporium Brand Products 13 oz. Plastic Tray UPC: 1119079011 Best if used by date range: 11/6/15 12/10/15 Class I Salmonella Aurora Products, Inc.
Food 5 K Omega Trail Mix: Aurora 20 oz. Plastic Cup UPC: 65585200121; Aurora, 10 oz. Plastic Cup UPC: 65585200703; Belmont Market 10 oz. Plastic Cup; UPC: 65585200703; Gourmet Garage 10 oz. Plastic Cup UPC: 79084505947 Union Market 10 oz. Plastic Cup UPC: 65585200703 Best if used by date range: 11/3/15 11/16/15 Class I Salmonella Aurora Products, Inc.
Food 6 Section Nut Tray Assortment: Aurora, 26 oz. Plastic Tray, UPC: 65585200145; Food Emporium Brand, 26 oz. Plastic Tray, UPC: 1119079012 Best if used by date range: 11/6/15 12/10/15 Class I Salmonella Aurora Products, Inc.
Food Cranberry Health Mix: America Choice, 16 oz. Plastic Pouch, UPC: 75480779046; Aurora , 9.25 oz. Plastic Cup, UPC: 65585200288; Aurora , 10.0 oz. Pillow Pouch, UPC: 65585200826; Aurora, 16.0 oz. Plastic Pouch, UPC: 65585200827, Aurora , 18 oz. Plastic Pouch , NO UPC; Aurora , 21 oz. Plastic Cup, UPC: 65585200585; Aurora , 4.5 oz. Single Serve, UPC: 65585200208; Aurora, 1.35 oz. Single Serve, UPC: 65585200574; Aurora Bulk, NO UPC; Belmont Market , 9.25 oz. Plastic Cup, UPC: 65585200288; Belmont Market, 21 oz. Plastic Cup, UPC: 65585200585; Citarella Brand Products, 9.25 oz. Plastic Cup, UPC: 79084505949; Citarella Brand Products, Bulk, NO UPC; Food Emporium Brand Products, 7.5 oz. Gift Bag, UPC: 1119079044; Food Emporium Brand Products, 21 oz. Plastic Cup, UPC: 1119079010; Gauls Market Brand Products, 9.25 oz. Plastic Cup, UPC: 65585200288, Gauls Market Brand Products, 21 oz. Plastic Cup, UPC: 65585200585; Giant Carlisle Food Store, 21 oz. Plastic Cup, UPC: 68826713692; Giant Carlisle Food Store, 9.25 oz. Plastic Cup, UPC: 68826714713; Giant of Maryland, 21 oz. Plastic Cup, UPC: 68826713692; Giant of Maryland, 9.25 oz. Plastic Cup, UPC: 68826714713; Gourmet Garage, 9.25 oz. Plastic Cup, UPC: 79084505949; Gourmet Garage, 21 oz. Plastic Cup, UPC: 79084505603; Green Hills Market, 9.25 oz. Plastic Cup, UPC: 65585200288; Green Hills Market, 21 oz. Plastic Cup, UPC: 65585200585; Harvest Co Op Market , 9.25 oz. Plastic Cup, UPC: 65585200288; Hurley Ridge 9.25 oz. Plastic Cup, UPC: 65585200288; Hurley Ridge, 21 oz. Plastic Cup, UPC: 65585200585; Lees Market, 9.25 oz. Plastic Cup, UPC: 65585200288; Lees Market, 21 oz. Plastic Cup, UPC: 65585200585; Martins Food, 21 oz. Plastic Cup, UPC: 68826713692; Martins Food, 9.25 oz. Plastic Cup, UPC: 68826714713; Miles Market, 9.25 oz. Plastic Cup, UPC: 65585200288; Stop & Shop, 21 oz. Plastic Cup, UPC: 68826713692; Stop & Shop, 9.25 oz. Plastic Cup, UPC: 68826714713; Union Market , 9.25 oz. Plastic Cup, UPC: 65585200288; Whole Foods Market , 9.25 oz. Plastic Cup, UPC: 65585200288; Whole Foods Market , 21 oz. Plastic Cup, UPC: 65585200585; Wild Acorns , 9.25 oz. Plastic Cup, UPC: 81957401025; Wild Acorns, 16.0 oz. Plastic Pouch, UPC: 81957401114; Wild By Nature Brand Products, 9.25 oz. Plastic Cup, UPC: 65585270288; Windfall Market, 9.25 oz. Plastic Cup, UPC: 65585200288; Hannaford, 9.25 oz. Plastic Cup, 72543994563 Best if used by date range: 10/30/15 12/13/15 and 12/16/2015 Class I Salmonella Aurora Products, Inc.
Food Forest Bounty Grail Mix: Aurora, 13 oz. Plastic Cup, UPC: 65585200571; Aurora, 13 oz. Plastic Pouch, UPC: 65585200290; Aurora, 17.5 oz. Plastic Cup, UPC: 65585200496 Best if used by date range: 10/28/15 12/13/15 Class I Salmonella Aurora Products, Inc.
Food Raisin Nut Party Mix: Aurora, 11.0 oz. Plastic Cup, UPC: 65585200094; Ernest Klein, 11.0 oz. Plastic Cup, UPC: 65585200094, Food Emporium Brand Products, 7.5 oz. Gift Bag, UPC: 1119079050; Gauls Market Brand Products, 11.0 oz. Plastic Cup, UPC: 65585200094; Harvest Co Op Market, 11.0 oz. Plastic Cup, UPC: 65585200094; Hurley Ridge, 11.0 oz. Plastic Cup, UPC: 65585200094; Wild Acorns, 11.0 oz. Plastic Cup, UPC: 81957401031 Best if used by date range: 11/10/15 12/10/15 Class I Salmonella Aurora Products, Inc.
Food Roasted Mixed Nuts No Salt: Gourmet Garage, 9 oz. Plastic Cup, UPC: 79084506010; Hannaford, 9.0 oz. Plastic Cup, UPC: 72543994507 Best if used by date range: 11/10/15 12/19/15 Class I Salmonella Aurora Products, Inc.
Food San Fernando Sunshine Mix: Gourmet Garage, 11 oz. Plastic Cup, UPC: 79084505936 Best if used by date range: 11/10/15 12/19/15 Class I Salmonella Aurora Products, Inc.
Food Deluxe Mixed Nuts with Sea Salt: Aurora, Bulk; Gourmet Garage, 9 oz. Plastic Cup, UPC: 79084505945 Best if used by date range: 11/18/15 12/19/15 Class I Salmonella Aurora Products, Inc.
Food Deluxe Mixed Nuts No Salt: Aurora, Bulk, NO UPC Best if used by date range: 11/18/15 12/19/15 Class I Salmonella Aurora Products, Inc.
Food Roasted Salt Mixed Nuts: Aurora, 4.5 oz. Plastic Pouch, UPC: 65585200252; Aurora, 20 oz. Plastic Tub, UPC: 65585200340; Aurora, 10 oz. Plastic Pouch, UPC: 65585200804, Aurora, Bulk, No UPC, Belmont Market, 20 oz. Plastic Tub, UPC: 65585200340, Food Emporium Brand Products, 6.5 oz. Gift Bag, UPC: 1119079042; Food Emporium Brand Products, 20 oz. Plastic Tub, UPC: 1119079095, Gauls Market Brand Products, 20 oz. Plastic Tub, UPC: 65585200340; Giant Carlisle Food Store, 9.0 oz. Plastic Cup, UPC: 68826714736; Giant of Maryland, 9.0 oz. Plastic Cup, UPC: 68826714736; Martins Food, 9.0 oz. Plastic Cup, UPC: 68826714736; Stop&Shop, 9.0 oz. Plastic Cup, UPC: 68826714736; Aurora, 9.0 oz. Plastic Cup, UPC: 65585200084; Ernest Klein, 9.0 oz. Plastic Cup, UPC: 65585200084; Gauls Market Brand Products, 9.0 oz. Plastic Cup, UPC: 65585200084; Harvest Co Op Market, 9.0 oz. Plastic Cup, UPC: 65585200084; Hurley Ridge, 9.0 oz. Plastic Cup, UPC: 65585200084 11/4/15 12/13/15 Palmers Market Roasted Salt Mixed Nuts 9.0 oz. Plastic Cup 65585200084 11/4/15 12/13/15 Wild Acorns Roasted Salt Mixed Nuts 9.0 oz. Plastic Cup 81957401052 11/4/15 12/13/15 Wild By Nature Brand Products Roasted Salt Mixed Nuts 9.0 oz. Plastic Cup 65585270084 11/4/15 12/10/15; Gourmet Garage, 9 oz. Plastic Cup, UPC: 79084505922; Gourment Garage, 20 oz. Plastic Tub, UPC: 79084505842 Best if used by date range: 11/18/15 12/19/15 Class I Salmonella Aurora Products, Inc.
Food Spinach & Goat Cheese Pizza (Focaccia) Mackenzie Limited Spinach & Goat Cheese Focaccia 18 PCS #SGC18 Products are placed on plastic trays, shrink wrapped, placed in boxes, labelled, & shrink wrapped. 11/17/2014 11/20/2014 01/14/2015; Mackenzie Limited 02/19/2015 11/14/2014 11/17/2014 01/30/2015 Class II Products may contain peanut protein. Gourmet Kitchen, Inc.
Food Asparagus Roll Ups; Asparagus Roll-Up 100 PCS v2002 15075 Products are placed on plastic trays, shrink wrapped, placed in boxes, labelled, & shrink wrapped. 11/13/2014; Asparagus Roll-Up 100 PCS 11/03/2014 11/13/2014 12/04/2014 12/19/2014 01/14/2015 01/20/2015 01/29/2015 02/10/2015 02/18/2015 Class II Products may contain peanut protein. Gourmet Kitchen, Inc.
Food Shrimp Maui; Maui Shrimp 100 pcs S5036 15075 Products are placed on plastic trays, shrink wrapped, placed in boxes, labelled, & shrink wrapped. 11/21/2014 02/27/2015; Maui Shrimp 100 pcs 10/24/2014 11/07/2014 11/21/2014 12/09/2014 12/16/2014 01/09/2015 01/19/2015 01/23/2015 01/30/2015 02/06/2015 02/27/2015 Class II Products may contain peanut protein. Gourmet Kitchen, Inc.
Food Lobster & Shrimp Spring Rolls Products are placed on plastic trays, shrink wrapped, placed in boxes, labelled, & shrink wrapped. 11/10/2014 12/17/2014 01/21/2015 Class II Products may contain peanut protein. Gourmet Kitchen, Inc.
Food Appetizer Size Lobster Spring Rolls 80 PCS L1046 15075 Products are placed on plastic trays, shrink wrapped, placed in boxes, labelled, & shrink wrapped. 10/27/2014 11/17/2014 Class II Products may contain peanut protein. Gourmet Kitchen, Inc.
Food Spicy Shrimp Chopsticks 80 PCS S5038 15075 Products are placed on plastic trays, shrink wrapped, placed in boxes, labelled, & shrink wrapped. 10/28/2014 11/14/2014 12/04/2014 12/09/2014 12/15/2014 01/06/2015 01/13/2015 01/20/2015 Class II Products may contain peanut protein. Gourmet Kitchen, Inc.
Food Apricot Filled Cookie OTC Sell By: (all dates up to) 3/23/2015 Net WT. 1 OZ Contains:Egg, Wheat, Soy ; OTC Raisin Filled Cookie Sell By: (all dates up to) 3/23/2015 Net WT 2 OZ Contains: Egg, Wheat Soy ; Cookies affected are only sold direct from bakery counter and packaged at time per customer request and packed either in clam shell plastic or wax paper. ; Net Weight on label may differ depending on number of cookies a customer requested. Net Weights listed above are for 1 cookie. all dates up to 3/23/2015 Class I On 3/20/2015, it was discovered that the labels for Apricot Filled Cookie and Raisin Filled Cookie, served over the counter at retail Eagle and affiliate stores, did not declare the milk allergen. Milk was not included on the labels which state "contains: egg, wheat, soy." Giant Eagle, Inc.
Food Nature's Eats Natural Macadamia Nuts NET WT 6 oz. (170g) in clear cello bags, UPC: 8-32112-00912-7; Central Market Macadamia Nuts NET WT 6 oz. (170g) in clear cello bags, UPC: 8-32112-00820-5 Nature's Eats Lot Code: 31435001 BEST BY 23DEC15; 35014001 BEST BY 06JAN16; 35352001 BEST BY 26JAN16; 31133001 BEST BY 12DEC15. Macadamia Nuts Lot Code: 35090001 BEST BY 08JAN16; 35699001 BEST BY 17FEB16 Class I Product found positive for Salmonella. Texas Star Nut and Food Co., Inc.
Food Nature's Eats Mustang Island Macadamia Sunrise NET WT 14 oz. (397g) Trail Mixes in clear cello bags, UPC: 8-32112-00363-7 Lot Code: 35168001 BEST BY 15JAN16; 35542001 BEST BY 06FEB16; 35337001 BEST BY 26JAN16 Class I Product found positive for Salmonella. Texas Star Nut and Food Co., Inc.
Cosmetics Lulu DK JOICO TURN HEADS, Metallic Temporary Tattoos None Class III Product recalled due to undeclared ingredients. Tattoofun Inc
Drugs Methylcobalamin/Hydroxocobalamin Rx 3.125/3.125 mg/0.5 mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110 Lot#: 01272015@38, Exp 3/28/15 Class II Lack of assurance of sterility Fallon Wellness Pharmacy, L.L.C.
Drugs Methylcobalamin/B-Complex Rx 2.5/103 mg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110 Lot#: 02112015@35, Exp 4/12/15 Class II Lack of assurance of sterility Fallon Wellness Pharmacy, L.L.C.
Drugs Prostaglandin Rx, dispensed in 5 ml vials: 1) 10 mcg/mL Injection, 2) 22.5 mcg/mL Injection, 3) 45 mcg/mL Injection, 4) 60 mcg/mL Injection, 5) 80 mcg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110 Lot#: a) 10272014@1, Exp 4/27/15; b) 11042014@60, Exp 4/12/15; c) 11192014@43, Exp 4/12/15; d) 12042014@32, Exp 4/12/15; e) 12182014@46; Exp 4/12/15; f) 12232014@8, 12242014@16, Exp 4/12/15; g) 12312014@40, Exp 4/12/15 Class II Lack of assurance of sterility Fallon Wellness Pharmacy, L.L.C.
Drugs Papaverine/phentolamine/prostaglandin 30/4/0.04 mg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110 Lot #: a) 1031-2014@51; Exp 3/18/15; b) 12152014@24; Exp 4/12/15 Class II Lack of assurance of sterility Fallon Wellness Pharmacy, L.L.C.
Drugs Papaverine/phentolamine/prostaglandin 30/4/0.04 mg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110 Lot #: a) 1031-2014@51; Exp 3/18/15; b) 12152014@24; Exp 4/12/15 Class II Lack of assurance of sterility Fallon Wellness Pharmacy, L.L.C.
Drugs Papaverine/phentolamine/prostaglandin 30/1/0.025 mg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110 Lot#: 12012014@65; Exp 4/12/15 Class II Lack of assurance of sterility Fallon Wellness Pharmacy, L.L.C.
Drugs Papaverine/phentolamine/prostaglandin 16/0.5/0.005 mg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110 Lot#: 12172014@42; Exp 4/12/15 Class II Lack of assurance of sterility Fallon Wellness Pharmacy, L.L.C.
Drugs Papaverine/phentolamine/prostaglandin 30/1/0.01mg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110 Lot#: 12302014@9; Exp 4/12/15 Class II Lack of assurance of sterility Fallon Wellness Pharmacy, L.L.C.
Drugs Methylcobolamin 1) 6500 mcg/0.26mL, 2) 1000 mcg/0.08mL, 3) 5000mcg/mL, 4) 3000mcg/0.12mL, 5) 4000mcg/0.16mL, 6) 1000mcg/mL and 7) 1000 mcg/0.04mL injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110 Lot#: a) 02052015@53, Exp 4/6/15; b) 01142015@31, Exp 3/15/15; c) 02022015@6, Exp 4/3/15; d) 01132015@72, Exp 3/14/15; e) 01282015@57, Exp 3/29/15; f) 01302015@50, Exp 3/31/15; g) 01232015@14, Exp 3/24/15 Class II Lack of assurance of sterility Fallon Wellness Pharmacy, L.L.C.
Drugs Hydroxocobalamin 1) 1000mcg/mL, 2) 5mg/0.5mL, 3) 5000mcg/0.2mL injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110 Lot#: a) 02092015@59, Exp 4/10/15; b) 02122015@49, Exp 4/13/15; c) 02132015@44, Exp 4/14/15; d) 02192015@34, Exp 4/20/15 Class II Lack of assurance of sterility Fallon Wellness Pharmacy, L.L.C.
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W069114153730-part 1; W069114153730-part 2; W069114153390; W069114153101; W069114165177-part 1; W069114165177-part 2; W069114154990-part 1; W069114154990-part 2; W069114153151-part 1; W069114153151-part 2; W069114165215; W069114153732; W069114165175 Class II Blood products, which did not meet the acceptable product specifications, were distributed. Mississippi Blood Services Inc.
Biologics Red Blood Cells Leukocytes Reduced W045213992619 Class III Blood product, which tested negative for HTLV-I/II, but was collected from a donor who was previously deferred for testing positive for HTLV-I/II, was distributed. South Bend Medical Foundation, Inc.
Biologics Red Blood Cells Leukocytes Reduced W045214027120 Class II Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. South Bend Medical Foundation, Inc.
Biologics Red Blood Cells Leukocytes Reduced W051514101026 Class II Blood products, collected from a donor who traveled to a malarial endemic area, were distributed. Innovative Blood Resources
Biologics Red Blood Cells W051514045514 Class II Blood products, collected from a donor who traveled to a malarial endemic area, were distributed. Innovative Blood Resources
Devices Vitek 2 AST-YS06 REF 412 610, Fungal Susceptibility Card, 20 cards per carton, IVD. Intended for use with the Vitek 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant yeasts to antifungal agents when used as instructed. lot 286303720, expiration 08-APR-15 Class II The test kits have Out-of-Range-Low (OORL) Flucytosine QC results for Candida krusei ATCC 6258 Biomerieux Inc
Devices Vitek 2 AST-YS07 REF 414 967, Fungal Susceptibility Card, 20 cards per carton, IVD. Intended for use with the Vitek 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant yeasts to antifungal agents when used as instructed. lot 287303120, 02-APR-15; lot 287303122, 02-APR-15; lot 287306710, 08-MAY-15; lot 287308210, 23-MAY-15; lot 287311710, 27-JUN-15; lot 287314910, 29-JUL-15; lot 287314912, 29-JUL-15; lot 287315710, 06-AUG-15; lot 287317310, 22-AUG-15; lot 287317710, 26-AUG-15; lot 287318920, 07-SEP-15; lot 287319110, 09-SEP-15; lot 287319820, 16-SEP-15; lot 287321940, 07-OCT-15; lot 287322540, 13-OCT-15; lot 287323520, 23-OCT-15; lot 287324220,  ...
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Class II The test kits have Out-of-Range-Low (OORL) Flucytosine QC results for Candida krusei ATCC 6258 Biomerieux Inc
Devices Vitek 2 AST-YS01 REF 22 108, Fungal Susceptibility Card, 20 cards per carton, IVD. Intended for use with the Vitek 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant yeasts to antifungal agents when used as instructed. lot 281317710, 26-AUG-15; lot 281347810, 22-JUN-16; and lot 281350120, 15-JUL-16. Class II The test kits have Out-of-Range-Low (OORL) Flucytosine QC results for Candida krusei ATCC 6258. Biomerieux Inc
Biologics Source Plasma 370044172; 370042715; 370042450; 370041950; 370041642; 370039376; 370032435; 370032390 Class II Blood products, collected from a donor who received a tattoo within 12 months of donation, were distributed. Talecris Plasma Resources, Inc.
Devices Fujifilm Synapse® Cardiovascular I ProSolv® CardioVascular Synapse® Cardiovascular v4.0.8 Synapse® Cardiovascular v4.0.8 SR1 Intended Use: Picture Archiving and Communication System Computer, Diagnostic, Programmable Software Versions: Synapse® Cardiovascular v4.0.8 Synapse® Cardiovascular v4.0.8 SR1 Class II Under certain circumstances the patient Demographics in a report exported into the EMR may not match the demographics shown in the corresponding Synapse CV clinical report. Fujifilm Medical Systems U.S.A., Inc.
Devices FujiMedical Synapse® Cardiovascular I ProSolv® CardioVascular. A picture Archiving and Communication System Software versions: Synapse® Cardiovascular v4.0.8 Synapse® Cardiovascular v4.0.8 SR1 Software versions: Synapse® Cardiovascular v4.0.8 Synapse® Cardiovascular v4.0.8 SR1 Class II Measurement values in the EMR may not accurately reflect the actual measurement value on the Synapse Cardiovascular clinical report. Fujifilm Medical Systems U.S.A., Inc.
Food Plain Bagels; Sell By: (up to and including) 04/02/15; UPC: 67785 30499; Net Wt 22oz; Contains: Wheat; Giant Eagle; Distributed by Giant Eagle, Inc., Pittsburgh, PA 15238; Plastic bag contains 6 bagels. Sell By: (up to and including) 04/02/15; UPC: 67785 30499 Class II Giant Eagle recalls various products due to undeclared wheat & soy. Giant Eagle, Inc.
Food Asiago Bagels; Sell By: (up to and including) 04/02/15; UPC: 09741 30449; Net Wt 20oz; Contains: Wheat; Giant Eagle; Distributed by Giant Eagle, Inc., Pittsburgh, PA 15238; Plastic bag contains 6 bagels. Sell By: (up to and including) 04/02/15; UPC: 09741 30449 Class II Giant Eagle recalls various products due to undeclared soy. Giant Eagle, Inc.
Food Dinner Sourdough Bread; Sell By: (up to and including) 04/02/15; UPC: 67657 00199; Net Wt 9.0oz; Contains: Wheat; Giant Eagle; Distributed by Giant Eagle, Inc., Pittsburgh, PA 15238; Plastic bag contains 6 bagels. Sell By: (up to and including) 04/02/15; UPC: 67657 00199 Class II Giant Eagle recalls various products due to undeclared wheat & soy. Giant Eagle, Inc.
Food Lemon Almond Chicken Salad Wrap; Sell By: (up to and including) 04/01/15; UPC: 47235 80499; Net Wt 9.0oz; Keep Refrigerated; Giant Eagle; Distributed by Giant Eagle, Inc., Pittsburgh, PA 15238 Packed in rigid plastic. Sell By: (up to and including) 04/01/15; UPC: 47235 80499; Class II Giant Eagle recalls various products due to undeclared milk. Giant Eagle, Inc.
Food Lemon Almond Chicken Salad Wedge; Sell By: (up to and including) 04/01/15; UPC: 67093 20399; Net Wt 7.0oz; Keep Refrigerated; Giant Eagle; Distributed by Giant Eagle, Inc., Pittsburgh, PA 15238 Packed in rigid plastic. Sell By: (up to and including) 04/01/15; UPC: 67093 20399 Class II Giant Eagle recalls various products due to undeclared milk. Giant Eagle, Inc.
Food Lemon Almond Chicken Salad Sliders; Sell By: (up to and including) 04/01/15; UPC: 77183 60299; Net Wt 6.0oz; Keep Refrigerated; Giant Eagle; Distributed by Giant Eagle, Inc., Pittsburgh, PA 15238 2 sliders Packed in rigid plastic. Sell By: (up to and including) 04/01/15; UPC: 77183 60299 Class II Giant Eagle recalls various products due to undeclared milk. Giant Eagle, Inc.
Food Rotisserie Lemon Almond Chicken Salad; Sell By: (up to and including) 04/01/15; UPC: 55708 90899; Net Wt 16.0oz; Keep Refrigerated; Giant Eagle; Distributed by Giant Eagle, Inc., Pittsburgh, PA 15238 Rotisserie Lemon Almond Chicken Salad; Sell By: (up to and including) 04/01/15; UPC: 56839 60917; Net Wt 16.0oz; Keep Refrigerated; Giant Eagle; Distributed by Giant Eagle, Inc., Pittsburgh, PA 15238 Sell By: (up to and including) 04/01/15; UPC: 55708 90899; Sell By: (up to and including) 04/01/15; UPC: 56839 60917; Class II Giant Eagle recalls various products due to undeclared milk. Giant Eagle, Inc.
Food Giant Eagle Maryland Style Crab Cake; Sell By: 04/04/2015; PLU#: 47538; Contains Wheat, Egg, Soy, Milk; Keep Refrigerated; Distributed by Giant Eagle, Inc., Pittsburgh, PA 15238 Sell By: (up to and including) 04/04/15; PLU#47538 Class II Giant Eagle recalls various products due to undeclared fish/anchovies (worchestershire). Giant Eagle, Inc.
Food Starlight Candies Giant Eagle Bulk Candies Bulk Bin tag #63826 This product is sold from bulk bins only. No package label or codes. Class II Giant Eagle recalls various products due to undeclared soy lecithin. Giant Eagle, Inc.
Devices Dimension EXL with LM, Dimension EXL 200, Dimension RxL, Dimension RxL HM, Dimension RxL Max, Dimension RxL Max HM, Dimension Xpand, Dimension Xpand HM, Dimension Xpand Plus, Dimension Xpand Plus HM. The Dimension EXL clinical chemistry system is a discrete, random-access, microprocessor-controlled, integrated instrument/chemistry system that measures a variety of analytes, including enzyme activities, in body fluids for in vitro diagnostic use. Model numbers: D045912, D193440, D140066; Material Numbers: 10472176, 10636928, 10465412, 10461038, 10444828, 10444829, 10461849, 10461043, 10444837, 10444838 Class II Certain Dimension® Integrated Chemistry Systems Instrument Power Configurations may have been installed with a non-standard instrument power plug.The use of a non-standard plug configuration as described may lead to a potential electrical hazard. The likelihood of potential clinical impact or injury due to this issue is extremely low. Siemens Healthcare Diagnostics, Inc.
Cosmetics Nourish Organic Face Cream, Argan & Pomegranate, Sensible Organics Inc., Beaver Falls, PA 15010, 1.7 fl. oz./50 mL, Nourish Organic Face Cream packaged in 50 mL white barrel with airless pump & plastic cap, 12 units/case for each product Packaged Unit/UPC# 667383109036, Tester Unit/UPC# 667383209033; Lot numbers B34314, E24714, E24514, B10114, A07814, B06914, E04414, B00914, A33613 Class II All lot codes of Nourish Organic Face Lotion and Nourish Organic Face Cream were recalled because the products may contain mold. No illnesses have been associated with these products. Sensible Organics, Inc.
Cosmetics Nourish Organic Face Lotion, Argan & Rosewater, Sensible Organics Inc., Beaver Falls, PA 15010, 1.7 fl. oz./50 mL, in 2 oz. white cosmo oval with smooth black pump & plastic cap, 12 units/case for each product Packaged Unit/UPC# 667383109043, Tester Unit/UPC# 667383209040; Lot numbers: A01215, B24814, C24514, B10714, A07114, A36013, C34513, D34513, E34513, I29813, A21813 Class II All lot codes of Nourish Organic Face Lotion and Nourish Organic Face Cream were recalled because the products may contain mold. No illnesses have been associated with these products. Sensible Organics, Inc.
Food KT's Energy Bars, net weight per bar is 2.9 oz (82.21 g). no codes Class II KT's Energy Bars are recalled due to undeclared soy lecithin. Taylor Catering,LLC
Food KT's Energy Bars - Dairy Free!, net weight per bar is 2.9 oz (82.21 g). no codes Class II KT's Energy Bars - Dairy Free! are recalled due to undeclared soy lecithin. Taylor Catering,LLC
Food KT's Paleo Chocolate Chip Cookies, 2 cookies per package no codes Class II KT's Paleo Chocolate Chip Cookies are recalled due to undeclared soy lecithin. Taylor Catering,LLC
Food KT's Energy Bars No Nuts/Dairy Free. 2.9 oz./82.21 gram bar packaged in saran wrap no codes Class II KT's Energy Bars No Nuts/Dairy Free is recalled due to undeclared sulfite and because the coconut is declared in the ingredients statement but the product name is listed No Nuts. Taylor Catering,LLC
Food Terra Spice Company Jalapeno Cheddar (dry spice mix). Sold in 0.5, 1, 3, or 5 qt. jars, 6x10 stand up pouches, and bulk up to 50 lbs All lots-the firm does not place manufactuiring codes on products. Class II Greenies, LLC dba Terra Spice Co. decided to conduct a voluntary recall during an FDA inspection (inspection dates 3/24, 26/2015). Label lists cheddar and sour cream but does not specifically declare milk. Greenies LLC d.b.a. Terra Spice Company
Food Terra Spice Company the Greek (dry spice mix),New Kitchen Store the Greek (dry spice mix),Sawyer Home & Garden Center the Greek (dry spice mix),SPICE MERCHANTS the Greek. Sold in 0.5, 1, 3, or 5 qt. jars, 4x6 and 6x10 stand up pouches, and bulk up to 50 lbs All lots-the firm does not place manufactuiring codes on products. Class II Greenies, LLC dba Terra Spice Co. decided to conduct a voluntary recall during an FDA inspection (inspection dates 3/24, 26/2015). Label lists feta cheese but does not specifically declare milk. Greenies LLC d.b.a. Terra Spice Company
Food Terra Spice Company basil walnut pesto blend (dry spice mix), SPICE MERCHANTS basil walnut pesto blend. Sold in 0.5, 1, 3, or 5 qt. jars, 4x6 and 6x10 stand up pouches, and bulk up to 50 lbs All lots-the firm does not place manufactuiring codes on products. Class II Greenies, LLC dba Terra Spice Co. decided to conduct a voluntary recall during an FDA inspection (inspection dates 3/24, 26/2015). Label lists parmesan cheese and romano cheese but does not specifically declare milk Greenies LLC d.b.a. Terra Spice Company
Food Terra Spice Company Italian Seasoning w/ romano (dry spice mix), New Kitchen Store Italian seasoning w/ romano (dry spice mix), Regal Rabbit Italian seasoning w/ romano (dry spice mix), Sawyer Home & Garden Center Italian seasoning w/ romano),SPICE MERCHANTS Italian seasoning w/ romano. Sold in 0.5, 1, 3, or 5 qt. jars, 4x6 and 6x10 stand up pouches, and bulk up to 50 lbs All lots-the firm does not place manufactuiring codes on products. Class II Greenies, LLC dba Terra Spice Co. decided to conduct a voluntary recall during an FDA inspection (inspection dates 3/24, 26/2015). Label lists romano cheese but does not specifically declare milk Greenies LLC d.b.a. Terra Spice Company
Food Terra Spice Company buffalo wing rub (dry spice mix). Sold in 0.5, 1, 3, or 5 qt. jars, 4x6 and 6x10 stand up pouches, and bulk up to 50 lbs All lots-the firm does not place manufactuiring codes on products. Class II Greenies, LLC dba Terra Spice Co. decided to conduct a voluntary recall during an FDA inspection (inspection dates 3/24, 26/2015). Label does not declare soy and wheat. Greenies LLC d.b.a. Terra Spice Company
Food Terra Spice Company barbeque spice blend (dry spice mix), New Kitchen Store barbeque spice blend (dry spice mix), Sawyer Home & Garden Center barbeque spice blend, WILD ONION Spice Company barbeque spice blend. Sold in 0.5, 1, 3, or 5 qt. jars, 4x6 and 6x10 stand up pouches, and bulk up to 50 lbs All lots-the firm does not place manufactuiring codes on products. Class II Greenies, LLC dba Terra Spice Co. decided to conduct a voluntary recall during an FDA inspection (inspection dates 3/24, 26/2015). Label lists lecithin but does not specifically declare soy Greenies LLC d.b.a. Terra Spice Company
Drugs MONISTAT 1 SIMPLE CURE (Miconazole Nitrate Vaginal Insert) 1200 mg ovule, 1-DAY MAXIMUM STRENGTH TREATMENT OVULE per case, over-the-counter, Distributed by INSIGHT Pharmaceuticals, LLC, Trevose, PA 19053-8433, NDC 63736-013-30 Lot#: R18193, Exp 10/2016 Class III Marketed without an approved NDA/ANDA: The distributed units of Monistat 1 Simple Cure include only the 1200 mg vaginal suppository; the approved NDA requires both a 1200 mg vaginal suppository and the 2% topical cream. Medtech Products, Inc.
Food Central Market Teriyaki Salmon Jerky, 3 oz. per plastic retail pouch. The front label is correctly identified as Teriyaki Salmon Jerky, but the back side was mis-labeled as Smoked Salmon Jerky with the UPC 0 41220 34270 9. Best by Date: 08/25/2015 Class I Central Market Teriyaki Salmon Jerkey is recalled due to undeclared soy and wheat. World Wide Gourmet Foods, Inc. dba Alaska Smokehouse
Biologics Cryoprecipitated AHF, Pooled W200614913913; Class III Blood products, which were not quarantined subsequent to receiving information regarding a post donation illness, were distributed. American National Red Cross The
Biologics Blood and Blood Products for Reprocessing W200614306274; Class III Blood products, which were not quarantined subsequent to receiving information regarding a post donation illness, were distributed. American National Red Cross The
Biologics Red Blood Cells Leukocytes Reduced W088415504285; Class III Blood product, in which quality control and distribution/failure to quarantine unit due to medical history, was distributed. Blood Bank Of Hawaii
Devices Spinal Elements 5.5 x 45MM Mercury lordosed rod. A component of the Mercury Spinal System, comprised of a variety of screws, hooks, rods, connectors, and staples that are used for attachment to the non-cervical spine. Rods span the distance between screws and hooks and achieve fixation by the mechanical joining of the rods with the screws or hooks. Lordosed rods are pre-curved to better fit the patient anatomy. Part Number: 60100-045 Lot Numbers: 140086, 140449, 141013 Class III The firm is recalling three lots of 5.5 x 45MM Mercury lordosed rod because some products may not meet the appropriate traceability requirements including the lot number. Some rods were found to not include the product identification number (product number and lot number) marked directly on the rod. The lack of marking interrupts the ability to maintain traceability of the device. Spinal Elements, Inc
Biologics Platelets Pheresis Leukocytes Reduced W040715111730; W040715111730; Class III Blood products, for which quality control and distribution of products did not meet specifications, were distributed. Indiana Blood Center
Food Peterson's Macadamias Net Wt 16 oz. (454g) King Nut Companies Solon, OH 44139 www.petersonsnuts.com INGREDIENTS: Macadamia Nuts, Peanut and/or Canola Oil, Salt. 0 74870 10365 9 25 Lb box (Roasted Salted) Code = Item # 00265 - K/N Lot #  ...
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Class I The firm was notified by their supplier that the product test positive for Salmonella Kanan Enterprises, Inc.
Food Cleveland Crops Chili Cheezy Kale Chips Made with 100% Dehydrated Raw Kale, Raw, Gluten Free, Vegan, No Preservatives FRESH PRODUCE NO SUGAR ADDED CUYAHOGA COUNTY Board of Developmental Disabilities INGREDIENTS Raw Dehydrated Kale, Tomatoes, Lemon Juice, Chili Powder, Garlic Powder, Onion Powder, Sea Salt. NT WT 2 OZ (56.7) 8 58736 00504 8 No codes on product Class I The firm was notified by the Ohio Department of Agriculture that they failed to list Raw Cashews in their ingredient statement. Cleveland Crops Food Innovation Center
Devices TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma. Part Numbers: 04.037.012S 04.037.013S 04.037.014S 04.037.015S 04.037.017S 04.037.019S 04.037.021S 04.037.023S 04.037.025S 04.037.027S 04.037.028S 04.037.029S 04.037.031S 04.037.033S 04.037.035S 04.037.037S 04.037.039S 04.037.042S 04.037.043S 04.037.044S 04.037.045S 04.037.050S 04.037.051S 04.037.052S 04.037.053S 04.037.054S 04.037.055S 04.037.056S 04.037.057S 04.037.058S 04.037.059S 04.037.060S 04.037.061S 04.037.062S 04.037.063S 04.037.064S 04.037.065S 04.037.066S 04.037.067S 04.037.068S 04.037.069S 04.037.112S 04.037.120S 04.037.121S 04.037.123S 04.037.125S 04.037.127S 04.037.129S  ...
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Class II TFNA nails from certain lots were assembled with a locking mechanism too close to the top of the nail. Potential patient impact: surgical delay. Synthes, Inc.
Biologics Red Blood Cells Leukocytes Reduced W092915600086 Class III Blood product, collected from a donor whose hematocrit was tested using a device for which the quality control results were not documented, was distributed. Poudre Valley Health Care, Inc. Blood Bank
Devices ReTurn belt, wipeable, sizes Small through Extra Large, Plastic pouch, 1 item per pouch. Patient transfer aid. All affected product in the U.S are from the same LOT #1402S, Model #s 6133-6136 Class II Complaints were received that the heat-welded seam on the wipeable belt's strap tore when force was applied. No injuries were reported. Handicare USA, Inc.
Food Border Grill Tortilla Soup Item # BOR-010, 3 x 8 lbs bags/case with Lot Codes Numbers between 140409 and 150311 Corn Maiden Foods, Inc. 24201 Frampton Av. Harbor City, CA 90710 LOT # Expiration Date Frozen: Expiration After Thaw: 7 days Border Grill Tortilla Soup INGREDIENTS: Sauce: Water, tomato filets (tomatoes, salt, calcium, chloride, citric acid), fresh tomatoes, onion, garlic, jalapeno chile, chicken base (chicken meat including natural chicken juices, natural sea salt, chicken fat, vegetable extract (potato, carrot, onion), yeast extract, tumeric, natural flavors), Kosher salt, olive oil blend (olive oil, canola oil), chipotle chile, black pepper. COUNTAINS THE FOLLOWING ALLERGENS: NONE KEEP FROZEN OR REFRIGERATED 3 Bags x 8 lbs/Case Net Weights 24 lbs. Item # BOR-010, 3 x 8lbs bags/case with Lot Codes Numbers between 140409 and 150311 Class II The firm is recalling Border Grill Tortilla soup due to the product having undeclared hydrolyzed soy protein that is a sub-ingredient in the ingredient; chicken base. Corn Maiden Foods
Biologics Red Blood Cells Leukocytes Reduced W037714070711; Class III Blood product, collected from a donor who was at risk for leishmaniasis, was distributed. Hoxworth Blood Center
Drugs NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS CAPSULES, 100 mg, 100 count bottle, Rx Only --- Distributed by Alvogen, Inc. Pine Brook, NJ 07058; NDC 47781-303-01 Lot 457529, exp. 08/2016 Class II Failed Dissolution Specification; 6 month time point Alvogen, Inc
Food Tastefully Simple, Blackberry Syrup, 12 FL oz ( 360 ml), Item 763905. Ingredients: Corn syrup, blackberries, cane sugar, lemon juice, natural flavor. Container consists of Glass, flask bottle with black boot seal over cap/neck of bottle. These multi-product items also include Blackberry Syrup: Rise ,n Shine Assortment (Item: 101019). Springtime Celebrations Collection (Item: 100873; Savor Reward Items: 100876, 100885). TS EatWell Product Pack (Item: 100872; Savor Reward Items: 100879, 100878). Seasonal Favorites Product Pack (Item: 100874; Savor Reward Items: 100880, 100881). Large Consultant Assortment - no GWP (Item: 100860). Consultant Seasonal Assortment -  Large with GWP (Item: 100862). Lot Numbers 12182015 and 02032016 Class II Presence of suspected mold in some units. Tastefully Simple, Inc
Biologics Red Blood Cells Leukocytes Reduced W045214023197; Class II Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed. The Medical Foundation
Drugs Olanzapine, Orally Disintegrating Tablets, 5 mg, a) 30-count bottle (NDC 60505-3275-03), b) 100-count blister (NDC 60505-3275-00), Rx only, Manufactured by Apotex Inc. Toronto, Ontario Canada, M9L 1T9 Lot #: a) KL0655, Exp 04/15; KY2374, Exp 05/16; b) KL0656, Exp 04/15; KY2371, Exp 05/16 Class III Subpotent drug Apotex Inc.
Drugs Olanzapine, Orally Disintegrating Tablets, 10 mg, a) 30-count bottle (NDC 60505-3276-03), b) 100-count blister (NDC 60505-3276-00), Rx only, Manufactured by Apotex Inc. Toronto, Ontario Canada, M9L 1T9 Lot #: a) KY2389, Exp 05/16; b) KY2388, Exp 05/16 Class III Subpotent drug Apotex Inc.
Drugs Olanzapine, Orally Disintegrating Tablets, 20 mg, 30-count bottle, Rx only, Manufactured by Apotex Inc. Toronto, Ontario Canada, M9L 1T9 Lot # KL0664, Exp 04/15 Class III Subpotent drug Apotex Inc.
Devices Zimmer 100 mL Hemovac Device Hemovac Mini Evacuator. 00-2568-000-10. Zimmer Surgical, Inc. Intended for post-operative collection of wound drainage. Item #00-2568-000-10; Lot #62800843 Class III Devices were placed in a shipper carton without the appropriate number of the Instructions for Use (IFU). Packaging specifications require that each sales unit is accompanied by an IFU. Only one IFU was present in the shipper carton, instead of one IFU per each of the two sales units. Zimmer Surgical Inc
Food Purely Elizabeth Cranberry Cashew Ancient Grain Muesli, 10 ounces, packaged in plastic bag sealed into paper cartons, 6 packages per case, Manufactured by Natural Foodworks Group, LLC. Denver, CO Lot PMR0305151 , Best by date 03/05/2016 ; Lot PMR0402151 Best by date 04/02/2016 Class III Appetite for Healthy Living (DBA Purely Elizabeth) is recalling Cranberry Cashew Ancient Grain Muesli because an ingredient in this cereal contains sulfur dioxide, which is not declared on the label/ingredient statement. Natural Foodworks Group
Drugs Ortho-Cept (0.15 mg desogestrel and 0.03 mg ethinyl estradiol) tablets, 28- count blister (21 active tablets and 7 placebo tablets)/ 6 blister packs per carton. Rx only, Jointly Manufactured by: Janssen Ortho, LLC, Manati, Puerto Rico 00674 and NV Organon, Oss, The Netherlands, Manufactured for: Janssen Pharmaceuticals, Inc., Titusville, New Jersey 08560, New Jersey, NDC 50458-0196-15. Lot # 13CM724, Exp.09/15 (US) Lot # (L) 13DM732, Exp. 09/15 (Canada) Class II Subpotent Drug: 30 month timepoint Janssen Pharmaceuticals, Inc.
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W042314022575C; W042314022575C; Class II Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed. Blood Systems, Inc
Food Bountiful Harvest Chopped Spinach, KEEP FROZEN, Net Wt. 3 LBS. (1.36kg), Case with 12; Chopped Spinach (Cheney Brothers) 3 pounds, 12 per case; Essential Everyday Chopped Spinach Net Wt. 10 oz. (283g), 24 per case; Essential Everyday Chopped Spinach Net wt. 16 oz. (1 LB) 454g, 12 per case; Fareway Grade A Fancy Chopped Spinach Net WT 10 OZ (284 g), 24 per case; First Street Chopped Spinach Net Wt. 32 OZ (2 LB) 907g, 12 per case; Garden Fresh Grade A Fancy 1/20 LBS. Chopped Spinach, 1 bag per case; Markon First Crop Grade A Fancy Chopped Spinach 12/2 LBS., 12 per case; Springfield Fancy Chopped Spinach Net Wt 16 OZ (1 LB) 454g, 12 per case; West Creek Frozen Vegetables Chopped Spinach 1/20 LBS., 1 bag per case; Magic Harvest Chopped Spinach Net WT. 48oz. (3LBS) 1.36 kg, 12 per case; Magic Harvest Chopped Spinach Greens Distributed By: Magic Valley Frozen, LLC. McAllen, TX. 78504 1/35 LBS; Shur Fine Chopped Spinach Net WT 10 OZ (283 g), 24 per case; Cut Leaf Spinach (Cheney Brothers) 3 pounds, 12 per case; Essential Everyday Cut Leaf Spinach Net WT 10 oz, 24 per case; Essential Everyday Cut Leaf Spinach Net WT 16 oz. (1 LB) 454g, 12 per case; Springfield Fancy Cut Leaf Spinach Net WT 16 OZ (1 LB) 454g, 12 per case; Frost Sweet Cut Leaf Spinach Distributed By Diversifood Marietta, GA. 30067 Grade A Fancy Product of USA 1/35 LBS. Lot numbers: (Bountiful Harvest chopped) MV056515, MV05715, MV06015,  ...
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Class III Unapproved pesticide, Lambda-Cyhalothrin, used on the spinach and residual levels were found higher than 0.01 ppm Magic Valley Fresh Frozen, Inc
Drugs Sodium Sulfacetamide 9% and Sulfur 4.5% Wash Kit, Rx Only, Sodium Sulfacetamide 9% and Sulfur 4.5% Wash, Net Wt. 16 oz (454 g), Daily Moisturizing Wash, 16 fl. oz. (473 mL), Manufactured for: BioComp Pharma Inc., San Antonio, TX 78230, NDC 44523-0609-23 Lot #: 119814, Exp 05/31/2016 Class II Microbial Contamination of Non-Sterile Products: Product failed USP Microbial Limits Test. Mission Pharmacal Co
Drugs Sodium Sulfacetamide 9% and Sulfur 4.5% Wash Kit with Sunscreen, Rx Only, Sunscreen Broad Spectrum SPF 25, Net Wt. 3 oz (85 g), Sodium Sulfacetamide 9% and Sulfur 4.5% Wash Net Wt. 16 oz (454 g), Manufactured for: BioComp Pharma Inc., San Antonio TX, 78230, NDC 44523-616-23 Lot #: 526014, Exp. 05/31/2016 Class II Microbial Contamination of Non-Sterile Products: Product failed USP Microbial Limits Test. Mission Pharmacal Co
Devices HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit Product Usage: Is intended to repair the driveline cable once an electrical break has been identified. These repairs are limited to the portion of the driveline that is outside the patient boundary (exit side). Catalog #: ASY00116: HVAD Pump Driveline Splice Kit Lot #'s 532770, 567949, 480786, 483769, 490692, 539664, and 598189 and Catalog #: ASY00281: HVAD Pump Driveline Splicekit; Large OD Sheath Lot #'s 654090, 672401, 678800, 690423, 833963, 873159, and 880816 Class I Failures of the splice repair kit if exposed to excessive force. HeartWare Inc
Food D&D Foods, Inc. Summer Fresh Pasta 31830, packaged in 8-lb. plastic buckets. The firm name on the label is D&D Foods, Inc., Omaha, NE. Lot numbers and Best If Used By dates: 15093, APR. 24, 2015; 15096, APR. 27, 2015; 15100, MAY. 01, 2015; 15107, May. 08, 2015; 15113, MAY. 14, 2015; and 15114, MAY. 15, 2015.. Class I Product has the potential to be contaminated Listeria monocytogenes. D & D Foods, Inc.
Devices Tapered HD Upgrade Set, REF TSKHDUS, Non-Sterile, Rx Only, Product Usage Usage: Surgical instruments used in preparation for dental implant placement Lot Number 1501968 Class II BioHorizons Tapered HD Upgrade set was packaged with an incorrect drill component manufactured of stainless steel in place of the correct component manufactured from titanium. BioHorizons Implant Systems Inc
Drugs Levalbuterol Inhalation Solution, USP, 0.31 mg/ 3 mL, 3 mL Vials, Rx Only. Manufactured by: Cipla Ltd. Plot 9 & 10, Indure, SEZ, Pithampur, M.P.-454 775, INDIA, Manufactured for: Dr. Reddy's Laboratories, Inc., Princeton NJ 08640. NDC: 43598-412-25. Lot #: FA4022; Expiry: December 2015. Class III Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant. Cipla Limited
Devices Nuclear gamma cameras (ADAC VERTEX PLUS/SOLUS/CARDIO, ADAC VERTEX V60 & ADAC CARDIO C60) Nuclear gamma cameras intended to produce images depicting the anatomical distribution of single photon and positron emitting radioisotopes with the human body for interpretation by medical personnel. VERTEX PLUS/SOLUS/CARDIO Model #88297; Serial #s: 9504103, 9703171, 9802304, 9809124, 9809415, 9810438, 9910015, 9911711, _0002032, 0007001M, 0008009B, 0011002B, 0101002C, 0102019V, 0103020V, 01069VM, 01070VM, 0111001V, 01295VM, 01296K, 01864VM, 03026VM, 0939VM, 100098-01N, 1006, 1008, 10252, 1027, 1062701, 1062701, 10630, 1092, 1097, 11, 11090, 130234-01NVERTEX, 2035, 2038, 2047, 3059, 3060, 3064, 4007, 4078,  ...
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Class II The firm was notified by a customer that the collimator exchange carriage and the collimator storage cabinet were misaligned. Philips Medical Systems (Cleveland) Inc
Devices VenaSeal, Sapheon Closure System, Model # SP-101, VS-301 and VS-402. For vascular use. Model no. SP-101, Lots, 35766, 36191, 36192, 36617, 36618, 37621, 37622, 37399, 37400, 38263, 38286, 38407, 38417, 38756, 38863, 38864, 39113, 39336, 39378, 39670, 39739, 39848 and 40075.; Model no. VS-301, Lots 34193, 35585, 37007, 38804, 39111, 39123, 39469 and 40160; Model no. VS-402, Lots 39970, 39971, 39972, 39973, 40067,  ...
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Class II Possible sterility breach of the outer packaging (pouch) material which may compromise the outside surface sterility of the sealed inner tray. Covidien LLC
Food Poco Dolce Bittersweet Chocolate: Burnt Caramel Tile, sea salt topped; 0.6 oz (17 grams) San Francisco CA. Ingredients: Bittersweet Chocolate (Chocolate Liquor, Sugar, Cocoa Butter, Soy Lecithin, Pure Vanilla) Sugar, Butter, Grey Sea Salt. May contain traces of peanuts, tree nuts or milk proteins. no codes Class II California Department of Public Health conducted and inspection of the firm and found that milk was missing from the label as an ingredient of butter. Poco Dolce Confections, Inc.
Food Poco Dolce Bittersweet Chocolate: Almond Tile, sea salt topped; 0.6 oz (17 grams) San Francisco CA. Ingredients: Bittersweet Chocolate (Chocolate Liquor, Sugar, Cocoa Butter, Butter, Soy Lecithin, Pure Vanilla) Almonds, Grey Sea Salt. May contain traces of peanuts, tree nuts or milk proteins. no codes Class II California Department of Public Health conducted and inspection of the firm and found that milk was missing from the label as an ingredient of butter. Poco Dolce Confections, Inc.
Food Poco Dolce Bittersweet Chocolate: Almond Coconut Tile, sea salt topped; 0.6 oz (17 grams) San Francisco CA. Ingredients: Bittersweet Chocolate (Chocolate Liquor, Sugar, Cocoa Butter, Butter, Soy Lecithin, Pure Vanilla) Almonds, Coconut, Grey Sea Salt. May contain traces of peanuts, tree nuts or milk proteins. No codes Class II California Department of Public Health conducted and inspection of the firm and found that milk was missing from the label as an ingredient of butter. Poco Dolce Confections, Inc.
Food Poco Dolce Bittersweet Chocolate: Sesame Toffee Tile, sea salt topped; 0.6 oz (17 grams) San Francisco CA. Ingredients: Bittersweet Chocolate (Chocolate Liquor, Sugar, Cocoa Butter, Butter, Soy Lecithin, Pure Vanilla) Sugar, Butter, Sesame Seeds, Grey Sea Salt. May contain traces of peanuts, tree nuts or milk proteins. No codes Class II California Department of Public Health conducted and inspection of the firm and found that milk was missing from the label as an ingredient of butter. Poco Dolce Confections, Inc.
Food Poco Dolce Bittersweet Chocolate: Ginger Tile, sea salt topped; 0.6 oz (17 grams) San Francisco CA. Ingredients: Bittersweet Chocolate (Chocolate Liquor, Sugar, Cocoa Butter, Butter, Soy Lecithin, Pure Vanilla) Ginger, Sugar, Grey Sea Salt. May contain traces of peanuts, tree nuts or milk proteins. No codes Class II California Department of Public Health conducted and inspection of the firm and found that milk was missing from the label as an ingredient of butter. Poco Dolce Confections, Inc.
Food Poco Dolce Bittersweet Chocolate: Aztec Chili Tile, sea salt topped; 0.6 oz (17 grams) San Francisco CA. Ingredients: Bittersweet Chocolate (Chocolate Liquor, Sugar, Cocoa Butter, Butter, Soy Lecithin, Pure Vanilla) Pumpkin Seeds, Cinnamon, Ground Chiles, Grey Sea Salt. May contain traces of peanuts, tree nuts or milk proteins. No codes Class II California Department of Public Health conducted and inspection of the firm and found that milk was missing from the label as an ingredient of butter. Poco Dolce Confections, Inc.
Devices Nuclear Gamma Cameras (ADAC Vertex Classic, ADAC VERTEX PLUS/SOLUS/CARDIO, ADAC VERTEX V60) Philips Medical Systems, Cleveland, OH Vertex Classic; Model #: 890122; Serial #s: 9404100, 9601238, 9609084, 0407V, 0682V, 0795V, 0822VP2, 103, 20, 500, 5405V, 64, 9308007, 9309020, 9310032, 93-10660-1292, 9401059, 9401061, 9403076, 9403083, 9404106, 9407122, 9409148, 9410002, 9411006, 9411007, 9411016, 9501049, 9501210, 9502067, 9502086, 9503003, 9503079, 9503109, 9504019, 9505021, 9505124, 9506140, 9508169, 9508171, 9508184, 9508193, 9509198,  ...
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Class II During clinical use of a Vertex Plus Gamma Camera, as the detector heads were in the relative 180 degree position, Detector #1 drifted down and made contact with the patients chin during a whole body study acquisition. Philips Medical Systems (Cleveland) Inc
Devices GE Healthcare, CARESCAPE Monitor B850, B650 and B450 (Bx50). Mfg Lot or Serial # SED12394685GA SED12394688GA SED12404710GA SED12404711GA SED12404713GA SED12404716GA SED12404718GA SED12404720GA SED12404721GA SED12404722GA SED12404723GA SED12404725GA SED12445258GA SED12445259GA SED12445261GA SED12445262GA SED12445264GA SED12445265GA SED12445266GA SED12445268GA SED12445269GA SED12445298GA SED12445299GA SED12445309GA SEW12265533HA SEW13286489HA SEW14095097HA SEW14095105HA SEW14105496HA SEW14105497HA SEW14105502HA SEW14105503HA SEW14160623HA SEW14160626HA SEW14171213HA SEW14171313HA SEW14171314HA SEW14171315HA SEW14171317HA SEW14171319HA SEW14171320HA SEW14171321HA SKA14062508GA SKA14062511GA SKA14284377GA SKA14284378GA SKA14284382GA SKA14284385GA SKA14284388GA SKA14284393GA SKA14284394GA SKA14284395GA SKA14365356GA SKA14365375GA SKA14365378GA SKA14365380GA SKA14365382GA SKA14487159GA SKA14487160GA SKA14487161GA SKA14487162GA SKA14487163GA SKA14487165GA SKA14487166GA SKA14487168GA SKA14487170GA SKA14487171GA SKA14487172GA SKA14487173GA SKA14487174GA SKA14487175GA SKA14487176GA SKA14487178GA SKA14487180GA SKA14487182GA SKA14487185GA SKA14487218GA SKA15038500GA SKA15048558GA SMV15123913HA SMV15145547HA SMV15145548HA SMV15124159HA SEW12018091HA SKA13390428GA SKA13390435GA SKA13390440GA SKA13390468GA SKA13390474GA SKA13430502GA SKA13430503GA SKA13430504GA SKA13430505GA SMV15123911HA SED11067045GA SED12394559GA SKA14092755GA SMV15123912HA SED11229605GA SED11239640GA SED11239644GA SED11239645GA SED11239663GA SED11239664GA SED11239668GA SED11239669GA SED11239678GA SED11239679GA SED11239680GA SMV15123915HA Class II The heart rate could be calculated from pacer pulses without indication that pacemaker detection is OFF in some combinations of Bx50 monitors, a PDM, and CIC/CSCS. Then the monitor does not show the Pacer Off message and there may not be an alarm for asystole. Undetected asystole could result in irreversible changes in the patient´s condition and delayed or missed life sustaining patient treatment. GE Healthcare
Devices Spacelabs qube Compact Monitor, Model 91390. The monitor is functioning as either bedside or central monitors; passively displays data generated by Spacelabs Healthcare parameter modules, Flexports interfaces, and other SDLC based products in the form of waveform and numeric displays, trends and alarms. Serial Numbers: 1390-000054, 1390-000064, 1390-000313, 1390-000047, 1390-000898. Class II The input power can fail even though the power source at the wall has not been interrupted. In addition, there is the potential for the qube Compact Monitor to fail to turn on. This is a retrospective recall related to a recall initiated in 2012 (Z-0403-2013). Spacelabs Healthcare Inc
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