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High RiskFDA
Mylan Pharmaceuticals Inc
Capecitabine Tablets, USP, 500 mg, 120-count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-2512-78, UPC 3 0...
Oral Drugs·1,068 affected·Jun 30, 2015
RecallFDA
Glaxosmithkline Consmer Healthcare
Panadol (acetaminophen) Extra Strength, 500 mg, a) 30 count (UPC 1-03-53100-91070-8, NDC 0135-0135-02), b) 60 count (UPC 1-03-53100-91080...
Drugs·17,675 affected·Jun 30, 2015
High RiskFDA
Remel Inc
PathoDx Strep Grouping Kit, REF 62025, packaged 60 tests per kit. Latex agglutination test for identification of beta-hemolytic stre...
Medical Devices·1,859 affected·Jun 30, 2015
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA Chemistry Acetaminophen reagents; for in vitro diagnostic use in the quantitative determination of acetaminophen in human serum and...
Diagnostic Devices·1,032 affected·Jun 30, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis zee/ zeego systems; dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures...
Diagnostic Devices·586 affected·Jun 30, 2015
High RiskFDA
Hitachi Medical Systems America Inc
Hitachi Scenaria Computed Tomography System Hitachi Medical Systems America, Twinsburg, OH 44087
Medical Devices·33 affected·Jun 30, 2015
High RiskFDA
Ortho-clinical Diagnostics
VITROS 5,1 FS Chemistry System, Catalog Number/Product Code 6801375, Unique Device Identifier No. 10758750001132, and VITROS 5,1 FS Chemi...
Diagnostic Devices·6,801,375 affected·Jun 30, 2015
High RiskFDA
Fujifilm Medical Systems U.s.a., Inc.
Fujifilm Processor EPX 2500 High Definition Endoscopy; (Sales Brochure). For use in endoscopic procedures. Used to observe, record and ...
Medical Devices·0 affected·Jun 30, 2015
High RiskFDA
Fujifilm Medical Systems U.s.a., Inc.
Fujifilm Medical Endoscope for the duodenum and upper G.I. tract. ED-530XT, ED-250XT5, ED-250XL5, ED-450XT5, and ED-450XL5 Endoscope Ope...
Medical Devices·256 affected·Jun 30, 2015
High RiskFDA
Biotronik, Inc.
PSW 1203.U/1, PSW 1301.U, PSW 1307.U, PSW 1403.U, and PSW 1501.U Pacemaker Programmer software. Software approved for use with BIOTRONIK...
Cardiac Devices·768 affected·Jun 30, 2015
High RiskFDA
Remel Inc
PathoDx Strep B Grouping Latex, REF 62031, 3 ml packaged in plastic dropper bottle with a pink cap. Latex reagent for streptococcal ...
Diagnostic Devices·4,420 affected·Jun 30, 2015
High RiskFDA
Fujifilm Medical Systems U.s.a., Inc.
Fujinon/Fujifilm Processor EPX 2500 Operation Manual. For use in endoscopic procedures.
Medical Devices·60 affected·Jun 30, 2015
RecallFDA
Consumer Product Distributors Inc. Dba J Polep Distributif
RACHAEL'S GOURMET Candy Necklaces, Net Wt. 1.95 oz.; UPC: 0-77449-50452-9
Snacks & Candy·2,280 affected·Jun 29, 2015
RecallFDA
Qualitest Pharmaceuticals
HydrOXYzine Hydrochloride Tablets, USP 25 mg, Rx only, 100 count (NDC 0603-3968-21), 500 count (NDC 0603-3968-28) and 1000 count (NDC 06...
Oral Drugs·47,376 affected·Jun 29, 2015
High RiskFDA
Becton Dickinson & Co.
Enterococcus Screen Agar QUAD Plate
Medical Devices·770 affected·Jun 29, 2015
High RiskFDA
Covidien Lp (formerly Nellcor Puritan Bennett Inc.)
OxiMax N-560 Pulse Oximeter. For continuous or spot check monitoring of functional arterial oxygen saturation (SpO2) and pulse rate.
Respiratory Devices·105,831 affected·Jun 29, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc
Siemens Artis zee systems; dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedur...
Cardiac Devices·0 affected·Jun 29, 2015
High RiskFDA
Becton Dickinson & Co.
Vancomycin Screen Agar
Medical Devices·60,840 affected·Jun 29, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis Q systems; dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures includi...
Cardiac Devices·0 affected·Jun 29, 2015
High RiskFDA
Covidien Lp (formerly Nellcor Puritan Bennett Inc.)
OxiMax N-65 Handheld Pulse Oximeter. N65, N65-1, N65P, and N65P-1. For continuous or spot check monitoring of functional arterial ox...
Respiratory Devices·211,426 affected·Jun 29, 2015
High RiskFDA
Merit Medical Systems, Inc.
ReSolve Locking Drainage Catheters The ReSolve Locking Catheters are intended for percutaneous drainage of fluids from body cavities.
Surgical Devices·950 affected·Jun 29, 2015
RecallFDA
Baxter Healthcare Corp.
Baxter HomeChoice and HomeChoice Pro APD systems, designed to provide Automated Peritoneal Dialysis (APD) therapy for pediatric and adult...
Medical Devices·29,355 affected·Jun 29, 2015
CriticalFDA
Grand Bk Corp.
goodies by Nature RAW CASHEWS, NET WT. 9 oz (255g), held in clear plastic tubs, UPC code of 846034010055. Distributed By: Grand BK Corp....
Food·30 affected·Jun 27, 2015
High RiskFDA
Atkins Indiana Distribution Center
Atkins Chocolate Candies  5 ct. cartons - UPC code 637480075558
Snacks & Candy·5,846 affected·Jun 27, 2015
CriticalFDA
Vitamin Cottage Natural Food Markets, Inc.
Natural Grocers Caribbean Fruit & Nut Mix, Net Wt. (10 oz) (283g), packaged in plastic bag.
Produce·504 affected·Jun 26, 2015
High RiskFDA
Wismettac Asian Food
Seasoned Beanthread Salad (CHUKA ZENSAI), net wt. 2.2 lbs (1kg), Item No. 82021. Chinese style appetizer labeled as SEASONED BEANTHRE...
Produce·53 affected·Jun 26, 2015
CriticalFDA
Rocky Mountain Foods, Incorporated
Free Range Snack Co. Island Fruit and Nut Trail Mix, Net We 16 oz (454g)
Snacks & Candy·4,375 affected·Jun 26, 2015
CriticalFDA
Rocky Mountain Foods, Incorporated
Free Range Snack Co. Raw Macadamia Nuts, Net Wt. 15 LB. (6.80 kg), Ingredients: macadamia Nuts
Snacks & Candy·4,375 affected·Jun 26, 2015
RecallFDA
American Health Packaging
Desmopressin Acetate Tablets, 0.1 mg Tablets, Rx Only, Packed in 30 Tablet (3 x 10) Cartons. Packaged and Distributed by: American Healt...
Oral Drugs·341 affected·Jun 26, 2015
High RiskFDA
The Apothecary Shoppe Llc
SO-Acetylcysteine 10% Sterile Ophthalmic Solution, Rx Only, 10 mL bottle, Apothecary Shoppe, Compounding Pharmacy, Tulsa, OK 74135, NDC 1...
Ophthalmic Drugs·40 affected·Jun 26, 2015
High RiskFDA
The Apothecary Shoppe Llc
SIU-Tri-Mix 18/1/20 Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13861-1563-48
Injectable Drugs·55 affected·Jun 26, 2015
High RiskFDA
The Apothecary Shoppe Llc
S-Chorionic Gonad HCG 1000 U/mL Injection, Rx Only, 4 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 14294-1968-80
Injectable Drugs·98 affected·Jun 26, 2015
High RiskFDA
The Apothecary Shoppe Llc
SIU-Tri-Mix 24 mg/1 mg/10 mcg/mL, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13389-1152-36
Drugs·55 affected·Jun 26, 2015
High RiskFDA
The Apothecary Shoppe Llc
SIU-Papav/Phent 30/1 mg Inj., Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-6830-10
Drugs·55 affected·Jun 26, 2015
High RiskFDA
The Apothecary Shoppe Llc
S-Methylcobalamin 5000 mcg/mL Inj., Rx Only, 750 mL Container, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135
Drugs·750 affected·Jun 26, 2015
High RiskFDA
The Apothecary Shoppe Llc
SIU-Tri-Mix 30/2/20 Inj., Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13861-1398-47
Drugs·75 affected·Jun 26, 2015
High RiskFDA
The Apothecary Shoppe Llc
SIU-Tri-Mix 30/1/10 Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-2196-10
Injectable Drugs·67 affected·Jun 26, 2015
High RiskFDA
Ranbaxy Inc.
Absorica (isotretinoin) Capsules, 25 mg, Packaged in 3 x 10 Count Blister Cards/Box, Rx Only. Manufactured for: RANBAXY LABORATORIES, IN...
Oral Drugs·9,229 affected·Jun 26, 2015
RecallFDA
Vistapharm, Inc.
METOCLOPRAMIDE ORAL SOLUTION, USP 10 mg/10 mL, 10 mL cups, Rx only. Manufactured by VistaPharm, Inc, Largo, FL. NDC: 66689-031-01.
Oral Drugs·84,100 affected·Jun 26, 2015
High RiskFDA
The Apothecary Shoppe Llc
SIU-Papav/Phentol 30/.5 mg/mL Injection, Rx Only, 3 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-1775-01
Injectable Drugs·2 affected·Jun 26, 2015
High RiskFDA
The Apothecary Shoppe Llc
SIU-Papav/Phentol 30/1 mg/mL Injection, Rx Only, 5 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-6830-10
Injectable Drugs·70 affected·Jun 26, 2015
High RiskFDA
The Apothecary Shoppe Llc
SIH-Testosterone Cyp. 20 mg/mL Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13452-2896-05
Injectable Drugs·23 affected·Jun 26, 2015
High RiskFDA
The Apothecary Shoppe Llc
SIU-Tri-Mix 20/1 mg/10 mcg/mL, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13452-2913-85
Drugs·10 affected·Jun 26, 2015
High RiskFDA
The Apothecary Shoppe Llc
SIU-Tri-Mix 6/0.33/3.33 Injection Solution, Rx Only, 3 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13429-2007-70
Injectable Drugs·2 affected·Jun 26, 2015
High RiskFDA
The Apothecary Shoppe Llc
S-Methylcobalamin 1000 mcg/mL (PF) Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 14294-196...
Injectable Drugs·64 affected·Jun 26, 2015
High RiskFDA
The Apothecary Shoppe Llc
SIU-Tri-Mix 30/1/20 Injectable, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135,NDC 99999-2011-17
Injectable Drugs·113 affected·Jun 26, 2015
High RiskFDA
The Apothecary Shoppe Llc
SIU-Papav/Phent 24/1 mg/mL Inj., Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13861-1461-57
Drugs·20 affected·Jun 26, 2015
High RiskFDA
The Apothecary Shoppe Llc
SIU-Prostaglandin E1 20 mcg/mL Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-3169-01
Injectable Drugs·163 affected·Jun 26, 2015