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High RiskFDA
Pharm D Solutions, Llc
Phenol 5% and Glycerin Aqueous Solution 10 mL Injection, Pharm D Solutions, Houston, Texas --- NDC 69699-1431-10
Injectable Drugs·1,139 affected·Sep 10, 2018
High RiskFDA
Pharm D Solutions, Llc
Sermorelin/GHRP-2/GHRP-6 Mannitol 9 mg/9 mg/9 mg/300 mg Powder, Pharm D Solutions, Houston, Texas --- NDC 69699-1726-10
Drugs·420 affected·Sep 10, 2018
High RiskFDA
Pharm D Solutions, Llc
HCG 50,000 unit/0.3 gm Mannitol Lyophilized Powder Pharm D Solutions, Houston, Texas --- NDC 69699-1736-50
Drugs·114 affected·Sep 10, 2018
High RiskFDA
Pharm D Solutions, Llc
Pyridoxine 100 mg/mL, 30 mL MDV Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1614-30
Injectable Drugs·600 affected·Sep 10, 2018
High RiskFDA
Pharm D Solutions, Llc
Prostaglandin E1 80 mcg/mL Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1337-05
Injectable Drugs·189 affected·Sep 10, 2018
High RiskFDA
Pharm D Solutions, Llc
Bi-Mix Injection (Alprostadil 80 mcg/Lidocaine 2 mg/mL) Pharm D Solutions, Houston, Texas --- NDC 69699-1317-03
Injectable Drugs·115 affected·Sep 10, 2018
High RiskFDA
Pharm D Solutions, Llc
Bi-Mix (Papaverine/Phentolamine 150 mg/5 mg) a) Injectable NDC 69699-1760-15; b) (LYO) Powder NDC 69699-1760-15, Pharm D Solutions, Houst...
Injectable Drugs·29 affected·Sep 10, 2018
High RiskFDA
Pharm D Solutions, Llc
0.9% Sodium Chloride for Injection, 50 mL bags, Pharm D Solutions, Houston, Texas --- NDC 69699-1426-10
Injectable Drugs·12 affected·Sep 10, 2018
High RiskFDA
Pharm D Solutions, Llc
Sterile Water 50 mL Aqueous Solution, Pharm D Solutions, Houston, Texas --- NDC 69699-1421-50
Drugs·10 affected·Sep 10, 2018
High RiskFDA
Pharm D Solutions, Llc
Glycerin 72% (Lidocaine/Epi 2:1) Injectable, Pharm D Solutions, Houston, Texas ---- NDC 69699-1401-30
Injectable Drugs·180 affected·Sep 10, 2018
High RiskFDA
Pharm D Solutions, Llc
Sermorelin/Ipamorelin 18 mg/15 mg Powder, Pharm D Solutions, Houston, Texas --- NDC 69699-1759-18
Drugs·179 affected·Sep 10, 2018
High RiskFDA
Pharm D Solutions, Llc
HCG Reconstitued 50,000 IU Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1736-50
Injectable Drugs·3 affected·Sep 10, 2018
High RiskFDA
Pharm D Solutions, Llc
Magnesium 40 gm/ns 1000 mL IV, Pharm D Solutions, Houston, Texas --- NDC 69699-0904-10
Injectable Drugs·4 affected·Sep 10, 2018
High RiskFDA
Pharm D Solutions, Llc
Trimix T105 PGE/Phentolamine/Papaverine 10 mcg/30 mg/1 mg Injectable Pharm D Solutions, Houston, Texas --- NDC 69699-1351-05
Injectable Drugs·40 affected·Sep 10, 2018
High RiskFDA
Pharm D Solutions, Llc
Vigamox Oph. Solution Pharm D Solutions, Houston, Texas --- NDC 69699-0304-05
Drugs·521 affected·Sep 10, 2018
High RiskFDA
Pharm D Solutions, Llc
Zinc Sulfate 1 mg/mL MDV Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1418-10
Injectable Drugs·184 affected·Sep 10, 2018
High RiskFDA
Pharm D Solutions, Llc
Calcium Gluconate 10%, 100 mg/mL Injectable, Pharm D Solutions, Houston, Texas ---- NDC 69699-0914-30
Injectable Drugs·6,850 affected·Sep 10, 2018
High RiskFDA
Pharm D Solutions, Llc
Arginine Injections 100 mcg/mL, Pharm D Solutions, Houston, Texas NDC 69699-1414-20
Injectable Drugs·7,150 affected·Sep 10, 2018
High RiskFDA
Pharm D Solutions, Llc
QM-4A Quadmix 5 mL 30 PA-2PH-150A-Atropine 0.4 mg Aqueous Solution, Pharm D Solutions, Houston, Texas --- NDC 69699-1342-05
Drugs·25 affected·Sep 10, 2018
High RiskFDA
Pharm D Solutions, Llc
HCG 3000 Unit Powder, Pharm D Solutions, Houston, Texas --- NDC 69699-1738-10
Drugs·765 affected·Sep 10, 2018
High RiskFDA
Pharm D Solutions, Llc
Trimix Papaverine/Phentolamine/Alprostadil 30 mg/1 mg/60 mcg Powder Pharm D Solutions, Houston, Texas --- NDC 69699-1367-02
Drugs·430 affected·Sep 10, 2018
High RiskFDA
Pharm D Solutions, Llc
Calcium Gluconate 1% Eyewash Oph. Soln, 10 mg/mL, 1000 mL bottles, Pharm D Solutions, Houston, Texas ---- NDC 69699-0907-10
Drugs·25 affected·Sep 10, 2018
High RiskFDA
Pharm D Solutions, Llc
Calcium Gluconate1% Eyewash 10 mg/mL, 125 mL bottles, Pharm D Solutions, Houston, Texas ---- NDC 69699-0906-12
Drugs·29 affected·Sep 10, 2018
High RiskFDA
Pharm D Solutions, Llc
Bi-Mix Injection (Alprostadil 150 mcg/Lidocaine 2 mg/mL), Pharm D Solutions, Houston, Texas --- NDC 69699-1323-05
Injectable Drugs·130 affected·Sep 10, 2018
High RiskFDA
Pharm D Solutions, Llc
Lipo MIC-12 Compound Injectable a) NDC 69699-1603-10; b) 30 mL Stock Solution Compound Injectable NDC 69699-1603-30, Pharm D Solutions, H...
Injectable Drugs·896 affected·Sep 10, 2018
High RiskFDA
Pharm D Solutions, Llc
Phenol 7% and Glycerin Aqueous Solution 10 mL Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1432-10
Injectable Drugs·630 affected·Sep 10, 2018
High RiskFDA
Pharm D Solutions, Llc
Trimix ST-1 30PA-1.5PH-50A Aqueous Solution Pharm D Solutions, Houston, Texas --- NDC 69699-1388-05
Drugs·40 affected·Sep 10, 2018
High RiskFDA
Howmedica Osteonics Corp.
Sterile Knee Instruments Disposable Fluted Headless Pins, DIA 3.2mm LNTH 89mm, REF 7650-2038A - Product Usage: Howmedica Osteonics Corp. ...
Surgical Devices·15 affected·Sep 10, 2018
High RiskFDA
Boston Scientific Corporation
VALITUDE X4 CRT-P (Cardiac Resynchronization Therapy Pacemaker)
Cardiac Devices·0 affected·Sep 10, 2018
High RiskFDA
Boston Scientific Corporation
PROPONENT Pacemaker
Cardiac Devices·0 affected·Sep 10, 2018
High RiskFDA
Ge Healthcare Biosciences
DeltaVision OMX SR Imaging System Model Number: 29115476 The DeltaVision OMX SR Imaging System is a piece of laboratory equipment for...
Medical Devices·39 affected·Sep 10, 2018
High RiskFDA
Boston Scientific Corporation
ACCOLADE Pacemaker
Cardiac Devices·0 affected·Sep 10, 2018
High RiskFDA
Vivorte, Inc.
Vivorte Trabexus EB 10 cc Bone Void Filler -Fill bone and/or defect in skeletal system Model Number: 130703-10
Medical Devices·12 affected·Sep 9, 2018
High RiskFDA
Noven Pharmaceuticals, Inc.
Minivelle (estradiol transdermal system) Patches, Delivers 0.025 mg/day, 8 count boxes, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Mia...
Topical Drugs·26,217 affected·Sep 7, 2018
High RiskFDA
Noven Pharmaceuticals, Inc.
Minivelle (estradiol transdermal system) Patches Delivers 0.1 mg/day, a) 2 count and b) 8 count boxes, Rx only, , Mfd. by: Noven Pharmace...
Topical Drugs·213,714 affected·Sep 7, 2018
High RiskFDA
Noven Pharmaceuticals, Inc.
Minivelle (estradiol transdermal system) Patches, Delivers 0.075 mg/day, 8 count boxes, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Mia...
Topical Drugs·74,908 affected·Sep 7, 2018
High RiskFDA
Noven Pharmaceuticals, Inc.
Minivelle (estradiol transdermal system) Patches, Delivers 0.05 mg/day, a) 2 count and 8 count boxes, Rx only, Mfd. by: Noven Pharmaceuti...
Topical Drugs·149,631 affected·Sep 7, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista Lipase Flex Reagent Cartridge, Model Number 10461745 Product Usage: Dimension Vista - The LIPL method is an in vitro ...
Diagnostic Devices·3,956 affected·Sep 7, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Lipase Flex Reagent Cartridge, Model Number 10460277 Product Usage: Dimension - The LIPL method is an in vitro diagnostic t...
Diagnostic Devices·18,396 affected·Sep 7, 2018
High RiskFDA
Abbott Laboratories, Inc
APS Accelerator modular systems, 208-230 V-, 50/60 Hz, 1800 VA, IVD, RX, Class 2 Laser Product,
Medical Devices·159 affected·Sep 7, 2018
High RiskFDA
Bayer Medical Care, Inc.
Codan Filter (Codan catalog number BC 693) used with Medrad Patient Administration Sets (PAS) and Intego PET Infusion Systems Product ...
Medical Devices·1,142,836 affected·Sep 7, 2018
High RiskFDA
Vital Scientific N.v.
V-Twin, Catalog # 6002-800, UDI: 03661540600180 - Product Usage: An in vitro diagnostic device, which is an automated chemistry analyzer,...
Diagnostic Devices·192 affected·Sep 7, 2018
High RiskFDA
Baxter Healthcare Corporation
0.9% Sodium Chloride Injection USP 50 mL Viaflex container Baxter Healthcare Corporation Deerfield, IL 60015 -- NDC 0338-0049-31
Injectable Drugs·5,184 affected·Sep 6, 2018
High RiskFDA
Implant Direct Sybron Manufacturing, Llc
Implant Direct Scan Adapter Assembly Replant platform for the following part numbers: 6035-09PT-M (3.5mmD)/UDI : 10841307123934,;6043-09P...
Medical Implants·107 affected·Sep 6, 2018
High RiskFDA
Cryolife, Inc.
CryoPatch SG Pulmonary Hemi-Artery, 1 graft
Medical Devices·1 affected·Sep 6, 2018
High RiskFDA
Wismettac Asian Foods (usa) Dba Nishimoto Trading Co Ltd
EVERYBURGER - Burger-Shaped Chocolate Cookies: NET WT. 2.32 oz. (66 g) There are 2 packing sizes; 10 items per case and 80 items per ca...
Bakery & Grains·40,197 affected·Sep 5, 2018
High RiskFDA
Cordis Corporation
Cordis POWERFLEX PRO PTA Dilatation Catheter - Product Usage: Is intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, ...
Medical Implants·162 affected·Sep 5, 2018
High RiskFDA
Thoratec Switzerland Gmbh
Thoratec CentriMag Motor, Model: 102956, a component of the Thoratec CentriMag Blood Pumping System and PediMag Blood Pumping System.
Medical Devices·1,569 affected·Sep 5, 2018