Retiros de la FDA, junio 2015: 98 publicados

48 empresas distintas aparecen este mes.

Clasificación de riesgo: Class I: 23 · Class II: 69 · Class III: 6

Mismo mes, otras agencias:CPSC 23 retirosFSIS 11 retirosNHTSA 88 retiros

Retiros del mes

FechaProducto
24 de junio de 2015Amlodipine besylate and Atorvastatin calcium tablets, 5mg/10mg, packaged in a)30-count bo…D-1143-2015Dr. Reddy's Laboratories, Inc.
24 de junio de 2015Fentanyl Citrate Inj., USP, CII, 250 mcg/5 mL (50 mcg/mL) (0.05 mg/mL), Rx Only, For IV o…D-1139-2015West-Ward Pharmaceutical Corp.
24 de junio de 20153.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws; . the Cannulated Sc…Z-1800-2015Synthes, Inc.
24 de junio de 2015Pull Reduction Device For 4.3mm Percutaneous Drill Guide; The pull reduction device with …Z-1799-2015Synthes, Inc.
24 de junio de 2015BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Glove Part Nu…Z-1805-2015Beaver-Visitec International Inc.
24 de junio de 2015Lamivudine and Zidovudine Tablets USP 150mg/300mg 30 Unit Dose Blisters, Rx Only, Package…D-1140-2015American Health Packaging
24 de junio de 2015Brown Peeled and De-veined Shrimp, (U/10, U/12, 10/15, 16/20, 21/25, 26/30, 31/35, 36/40,…F-2444-2015Texas Pack, Inc.
24 de junio de 2015Viking M, L, and XL Mobile Lifts. Non-AC-powered patient lift.Z-1818-2015Hill-Rom, Inc.
24 de junio de 2015Desiccated Coconut Distributed by: Phildesco , Inc. Somerset, New Jersey 08873 USAF-2731-2015Phildesco Inc.
24 de junio de 2015NEXIUM¿ (esomeprazole magnesium), Delayed-Release capsules, 20 mg, 30-count bottle, Rx on…D-1141-2015AstraZeneca Pharmaceuticals LP
17 de junio de 2015Sugar Free Carrot Cake 2 ozF-2434-2015AYAA Popcorn Manufacturing Corp.
17 de junio de 2015Glutathione INHALATION (PF), solution, 100mg/mL, 4 mL vial, Rx only, dispensed by Montana…D-1121-2015Montana Compounding Pharmacy
17 de junio de 2015Kr8om Max2 All-Natural Extraction, Formulation, and Distribution by NUEVOtanicals, LLC Fo…F-2414-2015Nuevotanicals
17 de junio de 2015Unilateral external fixation ankle clamp Product Usage: Unilateral external fixation …Z-1741-2015Biomet, Inc.
17 de junio de 2015REACTION RECOR: Pre Action- 336g Orange Xplosion, Distributed by Reaction Nutrition, Carn…F-2399-2015Reaction Nutrition LLC
17 de junio de 2015CRIT-LINE Blood Chamber- an accessory to the Crit line III- Monitors in real time blood p…Z-1716-2015Fresenius Medical Care Holdings, Inc.
17 de junio de 2015GEMINI TF Big Bore (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomogr…Z-1789-2015Philips Medical Systems (Cleveland) Inc
17 de junio de 20151-lb, 2-lb and 10-lb bags of Mung Bean Sprouts in clear plastic bags labeled GOODSEED Mun…F-2431-2015Good Seed, Inc.
17 de junio de 2015Kr8om Max3 All-Natural Extraction, Formulation, and Distribution by NUEVOtanicals, LLC Fo…F-2413-2015Nuevotanicals
17 de junio de 2015Alprostadil (PFE1), solution, 30 mcg/mL, injectable, 5 mL vial, Rx only, compounded by Mo…D-1128-2015Montana Compounding Pharmacy
17 de junio de 2015100% NATURAL HERBAL MIND & BODY SHOT greenjoy Sustained, Relaxed Energy Supports Mood …F-2412-2015Nuevotanicals
17 de junio de 2015RN BlueChip: Glutamine, L-Glutamine Powder, 400 grams, Distributed by Reaction Nutrition,…F-2397-2015Reaction Nutrition LLC
17 de junio de 2015Max powder in Ziploc-type freezer bags in 500 g increments, no product labelF-2416-2015Nuevotanicals
17 de junio de 2015Ingenuity PET/MR (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomogra…Z-1780-2015Philips Medical Systems (Cleveland) Inc
17 de junio de 2015HeartWare Ventricular Assist System (HVAD) For use as a bridge-to-cardiac transplantation…Z-1751-2015HeartWare Inc
17 de junio de 2015MX 16 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-…Z-1759-2015Philips Medical Systems (Cleveland) Inc
17 de junio de 2015REACTION RECOR: Amino Action- 500g (Cherry Lime), Distributed by Reaction Nutrition, Carn…F-2395-2015Reaction Nutrition LLC
17 de junio de 2015PHENYLephrine HCl 50 mg in 0.9% Sodium Chloride 250 mL bag (Concentration = 0.2 mg per mL…D-1133-2015SCA Pharmaceuticals
17 de junio de 2015RN BlueChip: Creatine, Creatine Monohydrate, 400 grams, Distributed by Reaction Nutrition…F-2398-2015Reaction Nutrition LLC
17 de junio de 2015Sugar Free Vanilla Cake 2 oz.F-2433-2015AYAA Popcorn Manufacturing Corp.
17 de junio de 2015BBL Port A Cul tubes with Swabs Sterile Pack, catalog number 221607. For patient sample c…Z-1747-2015Becton Dickinson & Co.
17 de junio de 2015Bimix (PHENT;PAP) (N), solution, (10/300) 1 - 30 mg/mL, injectable, 5ml vial, Rx only, co…D-1120-2015Montana Compounding Pharmacy
17 de junio de 2015Bio Armor Carno Pump Plus Electrolytes 40 servings (Blue Raspberry), Distributed by Reac…F-2389-2015Reaction Nutrition LLC
17 de junio de 2015MX 16 Slice Phase II (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomo…Z-1760-2015Philips Medical Systems (Cleveland) Inc
17 de junio de 2015VITROS 5,1 FS Chemistry System, Software Version 2.8 & Below Automates pre-analytical …Z-1728-2015Ortho-Clinical Diagnostics
17 de junio de 2015Hyaluronidase (RM ONLY), Injectable Solution, 150 U/mL, 10ML vial, Rx only, compounded by…D-1123-2015Montana Compounding Pharmacy
17 de junio de 2015REACTION RECOR: Amino Action- 500g (Glacier Blue), Distributed by Reaction Nutrition, Car…F-2396-2015Reaction Nutrition LLC
17 de junio de 2015Comprehensive Shoulder System, 4 mm, 122 mm long, Primary Shoulder Stem, Ti-6Al-4V, Stand…Z-1755-2015Biomet, Inc.
17 de junio de 2015250cc White Plastic Container containing 120 capsules, labeled Natural Creations New Zeal…F-2418-2015Natural Creations Inc
17 de junio de 2015R3(TM) 28 MM I.D., 60 MM O.D. CONSTRAINED LINER, REF 71339160, QTY: (1), STERILE EO, …Z-1738-2015Smith & Nephew, Inc.
17 de junio de 2015Heparin Sodium and 0.9% Sodium Chloride Injection, 1000 USP Heparin Units, 500 mL in a VI…D-1131-2015Baxter Healthcare Corp
17 de junio de 2015REACTION RECOR: Pre Action- 336g Glacier Blue, Distributed by Reaction Nutrition, Carnegi…F-2400-2015Reaction Nutrition LLC
10 de junio de 20153.2 mm Cannulated Drill Bit/ QC 170 mm 2.7 Cannulated Drill Bit/ QC 160 mm 2.0 mm Cann…Z-1711-2015Synthes, Inc.
10 de junio de 2015Frontier Natural Products Co-Op Pepper Fusion Black Peppercorns with Garlic Certified Org…F-2372-2015Frontier Natural Products Co-op
10 de junio de 2015Simply Organic Guacamole Dip Mix Certified Organic packaged in foil lined paper packet Ne…F-2385-2015Frontier Natural Products Co-op
10 de junio de 2015Frontier Natural Products Co-Op Fiesta Black Bean Mix Certified Organic packaged in a foi…F-2365-2015Frontier Natural Products Co-op
10 de junio de 2015Zebeta¿ (bisoprolol fumarate), tablets, 10mg, 30-count bottle, Rx only, Manufactured for …D-1112-2015Teva Pharmaceuticals USA
10 de junio de 2015Amy's Gluten Free Tofu Scramble Breakfast Wraps, 5.5 oz 156 g) 12 boxes per case. UPC: 0…F-2359-2015Amys Kitchen Inc
10 de junio de 2015Frontier Natural Products Co-Op Garlic Powder, Certified Organic, Non-Irradiated with res…F-2364-2015Frontier Natural Products Co-op
10 de junio de 2015Guayaki Brand Yerba Mate - Revel Berry; 16 oz aluminum can, Best By 12SEP16. UPC 6 3243…F-2346-2015Guayaki S.R.P., Inc.

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