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Recall Observatory FDA recall evidence

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Recalled products

The canonical enforcement rows. Everything else groups, enriches, or interprets these records.

Indexed record set

86,536 products

Page 3447 of 3462

Product Firm Event Initiated
Albuterol Sulfate Inhalation Solution, 0.083%, 2.5 mg/3 mL Sterile Unit-Dose Vials, 60-count (60 x 3 mL Sterile Unit-Dose Vials) per carton, Rx only, Manufactured by: nephron pharmaceuticals corporation, Orlando, FL 32811, NDC 0487-9501-60. Nephron Pharmaceuticals Corp. Event 62604 June 22, 2011
Azelastine HCl Nasal Solution, 0.1 %, 137 mcg/spray, 30 mL bottle (200 Metered Sprays), Rx only, Mfg by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, NDC 60505-0833-5. Apotex Corp. Event 62930 June 15, 2011
Z-800 Volumetric Infusion System. For intravenous infusion of parenteral fluids, blood and blood products to a human patient. Zyno Medical LLC Event 64448 June 13, 2011
Label reads in part "***OCHO RIOS***Spicy***Jerk***Curry***Distributed by :***Ocho Rios International***Miami, Florida 33142***Ingredients: Turmeric,***Fenugreek, Coriander, Cumin***Salt,*** Anise, Pepper, Pimento, Garlic***Degree of "Heat" 4-Hot***" Ocho Rios-Miami, Inc. Event 63018 June 01, 2011
Label reads in part "***OCHO RIOS***Jamaican***Curry***Seasoning***Net Wt. 4 & 8 oz (227 g)***Gold Series***Low Sodium***Extra delicious!***Distributed by :***Ocho Rios International***Miami, Florida 33142***Ingredients: Turmeric,***Fenugreek, Coriander, Cumin***Salt, Anise, Pimento, Garlic***"" Ocho Rios-Miami, Inc. Event 63018 June 01, 2011
Label reads in part "***OCHO RIOS***Hot***Jamaican***Curry***Gold Series***Extra delicious!***Distributed by :***Ocho Rios International***Miami, Florida 33142***Ingredients: Turmeric,***Fenugreek, Coriander, Cumin, Salt,*** Anise, Pepper, Pimento, Garlic***Degree of "Heat" 4-Hot***" Ocho Rios-Miami, Inc. Event 63018 June 01, 2011
Label reads in part "***OCHO RIOS***Mild***Jerk***Curry***Seasoning***Extra delicious!***Distributed by :***Ocho Rios International***Miami, Florida 33142***Ingredients: Turmeric,Allspice***Coriander, Fenugreek, Salt, Pepper,***Cumin, Garlic, Onion, Nutmeg,***Cinnamon, Thyme and spices***Degree of "Heat" 2 Mild"***" Ocho Rios-Miami, Inc. Event 63018 June 01, 2011
BioDerm Liberty 3.0 External Male Catheter Specialty Type with integral collection chamber (Component: SKIN-PREP Protective wipes). The recalled wipes are used on intact skin for applying skin protectant to the glands for control of male incontinence with an external, non-invasive and nonsterile device. BioDerm, Inc. Event 68313 May 31, 2011
BioDerm Liberty Pouch Clean & Dry External Male Catheter Specialty Type with integral collection chamber (Component: SKIN-PREP Protective wipes). The recalled wipes are used on intact skin for applying skin protectant to the glands for control of male incontinence with an external, non-invasive and nonsterile device. BioDerm, Inc. Event 68313 May 31, 2011
BioDerm Safe n' Dry 21006 (Component: SKIN-PREP Protective wipes). The recalled wipes are used on intact skin for applying skin protectant to the glands for control of male incontinence with an external, non-invasive and nonsterile device. BioDerm, Inc. Event 68313 May 31, 2011
Varian High Energy Clinacs, High Energy Accelerator, Radiation Treatment System, Model Numbers: H14, H27, H29, HCX. Product Usage: The Varian High Energy Accelerator is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. Varian Medical Systems, Inc. Oncology Systems Event 64997 May 31, 2011
All-In-One Probiotics, K12-BB12-LB3; Dietary Supplement; 30 Packets;Serving size 2 Tablets (1 Packet)l L141/1. Adults take 2 to 4 tablets daily; Children: take 1 to 2 tablets daily (or as directed by your healthcare practitioner. Chew slowly or allow to dissolve in mouth. Manufactured for Wynlife Healthcare, Inc., San Diego, CA 92130. Wynlife Healthcare, Inc. Event 64513 May 31, 2011
Vegi-Fiber Plus; O Trans Fat; only 15.4 Calories; Dietary Supplement; 60 Packets; Scientific formula for Natural Vitality; 15 Vegetable and Fruit Extracts; Newest Japanese Carbohydrate Blocker: Fibersol -2; Each Packet Contains 3.5g of Water-Soluble Dietary Fiber. Manufactured for Wynlife Healthcare, Inc., San Diego, CA 92130. Wynlife Healthcare, Inc. Event 64513 May 31, 2011
The product affected by this notice is sold under the trade name TomoTherapy SharePlan 1.1. To determine if the version you are using is affected, bring up the About box in the SharePlan application and check if the build number reported there is 1.3.1.10. Intended use: t-RayAutoplan is a software that, based on the planned dose distribution from a TomoPlan treatment planning system, generates a family of individually optimized IMRT plans and presents their characteristics to the user in a GUI. Among the generated plans, the user selects and clinically approves a treatment plan and exports it electronically to DICOM, for subsequent treatment of the patient. The intended users of t-RayAutoplan shall be clinically qualified staff, such as medical physicists, medical doctors or dosimetrists RAYSEARCH LABORATORIES AB Event 63110 May 30, 2011
PIRACETAM POWDER COGNITION ENHANCING AGENT Dietary Supplement CTD 500 grams PHARMACEUTICAL GRADECTD Labs Houston, TX 77090 A B Nutrition, Inc. Event 59001 May 27, 2011
PIRACETAM COGNITION ENHANCING AGENT Dietary Supplement PHARMACEUTICAL GRADE 800 mg 240 Capsules per bottle CTD Labs Houston, TX 77090 A B Nutrition, Inc. Event 59001 May 27, 2011
ANIRACETAM FAST ACTING NOOTROPIC Dietary Supplement PHARMACEUTICAL GRADE 750mg 60 Capsules per bottle CTD Labs Houston, TX 77090 A B Nutrition, Inc. Event 59001 May 27, 2011
Neptune¿ 2 Rover - ULTRA ~120V ~ 60 Hz 12A REF 0702-001-000, Rx, Caution, consult accompanying documents Consult instructions for use, Max Vacuum; 21.0 in-Hg, 530 mm-Hg, The Neptune Waste Management System consists of a mobile rover unit used to suction and collect fluid waste, small debris and electrocautery smoke from a surgical site. Mobility allows the rover unit to be relocated to a waste disposal area where the rovers collection canisters can be emptied, via the docking station. Intended to be used in the Operating Room, Surgical Centers and Doctors Offices to collect and dispose of surgical fluid waste as well as collect smoke from electrocautery or laser devices. Stryker Instruments Div. of Stryker Corporation Event 63634 May 24, 2011
Neptune¿ 2 Rover - ULTRA ~230V ~ 50 Hz 12A REF 0702-002-000, Rx Caution, consult accompanying documents Consult instructions for use, Max Vacuum; 21.0 in-Hg, 530 mm-Hg, The Neptune Waste Management System consists of a mobile rover unit used to suction and collect fluid waste, small debris and electrocautery smoke from a surgical site. Mobility allows the rover unit to be relocated to a waste disposal area where the rovers collection canisters can be emptied, via the docking station. Intended to be used in the Operating Room, Surgical Centers and Doctors Offices to collect and dispose of surgical fluid waste as well as collect smoke from electrocautery or laser devices. Stryker Instruments Div. of Stryker Corporation Event 63634 May 24, 2011
Percocet 10/325 mg tablets, 100-count tablets per bottle, Rx only, Dist. By: Physicians Total Care, Tulsa, OK 74146; Mfg. By: Novartis Consumer Health I, Lincoln, NE 68581; NDC 54868-4710-0, Barcode 47101006IHD. Physicians Total Care, Inc. Event 65002 May 23, 2011
***REF LS7600***Qty 1*** EC REP*** ConMed Linvatec Xenon Light Source Linvatec Corp. dba ConMed Linvatec Event 63009 May 20, 2011
***REF LS7700***Qty 1*** EC REP*** ConMed Linvatec Xenon Universal Light Source Linvatec Corp. dba ConMed Linvatec Event 63009 May 20, 2011
GE Healthcare, Innova 3100 and Innova 4100 systems. The Digital Fluoroscopic Imaging System is indicated for use in diagnostic and interventional angiographic procedures of human anatomy. It is intended to replace image intensifier fluoroscopic systems in all diagnostic or interventional procedures. GE Healthcare, LLC Event 65022 May 16, 2011
DPM Central Station Mindray DS USA, Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 The Central Monitoring Station (CMS) network transfers information between DOM Central Station and other network devices. It also allows information transfer between several CMS. Network connections consist of hardwired network cables and or WLAN connections. The DPM Central Station is used for remote monitor management, storing, printing, reviewing, or processing of information from net worked devices, and it is operated by medical personnel in hospitals or medical institutions. Mindray DS USA, Inc. d.b.a. Mindray North America Event 63616 May 12, 2011
Optima MR450w, Discovery MR450, Discovery MR750, Signa HDx, Signa HDxt, Signa HDi, Signa Vibrant, and GE 1.5T Signa HDe MR System. The GE Signa HDx MR system is a whole body magnetic resonance scanner. GE Healthcare, LLC Event 64291 May 10, 2011

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