Skip to main content
High RiskFDA
Geritrex, Llc
Preferred Plus Dioctyl Liquid Stool Softener (Docusate Sodium), 50mg/5mL, 16 FL. Oz. (1 PT.) 473 mL, Manufactured by RIJ Pharmaceutical C...
Drugs·15,435 affected·May 31, 2019
High RiskFDA
Chiesi Usa, Inc.
Zileuton Extended-Release Tablets, 600 mg, 120-count bottles, Rx only, Distributed by: Prasco Laboratories, Mason, OH 45040 USA; NDC 6699...
Oral Drugs·2,598 affected·May 31, 2019
High RiskFDA
Geritrex, Llc
Gericare Geri-Tussin DM, 16 FL OZ (473 mL), Geri-care Phamaceuticals Corp. 1650 63rd Street Brooklyn, NY, NDC 57896-660-16
Drugs·6,213 affected·May 31, 2019
High RiskFDA
Geritrex, Llc
Gericare Diocto Liquid Docusate Sodium Stool Softener, 50 mg/5mL, 16 FL OZ (473 ml), Dist. BY: Gericare Pharmaceuticals corp. 1650 63rd S...
Drugs·6,165 affected·May 31, 2019
High RiskFDA
Geritrex, Llc
Diphenhydramine Oral Liquid Alcohol Free, 12.5 mg/5 mL, 4 fl oz (118 mL), RIJ Pharmaceutical Corporation 40 Commercial Avenue Middletown,...
Oral Drugs·8,645 affected·May 31, 2019
High RiskFDA
Geritrex, Llc
Gericare Iron Supplement Elixir Ferrous Sulfate, 220 mg, 16 fl oz. (473 mL), Distributed by: Geri-care Pharmaceuticals Corp. 1650 63rd St...
Supplements·3,789 affected·May 31, 2019
High RiskFDA
Geritrex, Llc
Ritussin DM Double Strength, 4 FL. OZ. (118 mL), RIJ Pharmaceutical Corporation 40 Commercial Avenue Middletown, NY 10941
Drugs·7,653 affected·May 31, 2019
High RiskFDA
Chiesi Usa, Inc.
ZYFLO CR (zileuton) extended-release tablets, 600 mg, 120-count bottles, Rx only, Distributed by Chiesi USA, Inc., Cary, NC 27518, NDC 10...
Oral Drugs·2,118 affected·May 31, 2019
High RiskFDA
Geritrex, Llc
Ritussin DM Children & Adults, 4 Fl. Oz. (118 mL), RIJ Pharmaceutical Corporation 40 Commercial Avenue Middletown, NY 10941, NDC 53807-40...
Drugs·5,107 affected·May 31, 2019
High RiskFDA
Geritrex, Llc
Preferred Plus Pharmacy Iron Elixir Ferrous Sulfate, 220 mg, 16 fl oz. (473 mL), Distributed by: Geri-care Pharmaceuticals Corp. 1650 63r...
Drugs·3,864 affected·May 31, 2019
High RiskFDA
Bard Peripheral Vascular Inc
GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product code:5397270, 14.5F, straight, 27cm length, BARD, UDI: 00801...
Surgical Devices·887 affected·May 31, 2019
High RiskFDA
Baxter Healthcare Corporation
REVACLEAR 400 Dialyzer, Product Code 114746L Revaclear 300 and Revaclear 400 dialyzers are indicated for treatment of chronic and acu...
Medical Devices·65,403 affected·May 31, 2019
High RiskFDA
Bard Peripheral Vascular Inc
EQUISTREAM Long-Term Hemodialysis Catheter with Preloaded Styet, REF/Product code:5903310, 14.5F, Straight ,31cm length, BARD, UDI: 00801...
Surgical Devices·13 affected·May 31, 2019
High RiskFDA
Bard Peripheral Vascular Inc
GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product code:5397310, 14.5F, straight, 31cm length, BARD, UDI: 00801...
Surgical Devices·91 affected·May 31, 2019
High RiskFDA
Bard Peripheral Vascular Inc
GlidePath Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5393270, 14.5F, Straight, 27cm length, BARD, UDI: 00801...
Surgical Devices·2,298 affected·May 31, 2019
High RiskFDA
Bard Peripheral Vascular Inc
EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5913350, 16F, Straight, 35cm length, BARD, UDI: 00...
Surgical Devices·46 affected·May 31, 2019
High RiskFDA
Bard Peripheral Vascular Inc
GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product code:5397350, 14.5F, straight, 35cm length, BARD, UDI: 00801...
Surgical Devices·39 affected·May 31, 2019
High RiskFDA
Bard Peripheral Vascular Inc
EQUISTREAM XK Alphacurve Long-Term Hemodialysis Catheter REF/Product code:5915240, 16F, 24cm length, BARD, UDI: 00801741013904
Surgical Devices·0 affected·May 31, 2019
High RiskFDA
Bard Peripheral Vascular Inc
GlidePath Long-Term Hemodialysis Catheter, REF/Product code:5396190, 14.5F, Alphacurve, 19cm length, BARD, UDI: 00801741012242
Surgical Devices·240 affected·May 31, 2019
High RiskFDA
Bard Peripheral Vascular Inc
GlidePath Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5393420, 14.5F, Straight, 42cm length, BARD, UDI: 00801...
Surgical Devices·713 affected·May 31, 2019
High RiskFDA
Bard Peripheral Vascular Inc
GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product code:5397190, 14.5F, straight, 19cm length, BARD, UDI: 00801...
Surgical Devices·1,679 affected·May 31, 2019
High RiskFDA
Bard Peripheral Vascular Inc
GlidePath Long-Term Hemodialysis Catheter, REF/Product code:5396280, 14.5F, Alphacurve, 28cm length, BARD, UDI: 00801741012266
Surgical Devices·104 affected·May 31, 2019
High RiskFDA
Bard Peripheral Vascular Inc
EQUISTREAM Long-Term Hemodialysis Catheter with Preloaded Styet, REF/Product code:5903230, 14.5F, Straight ,23cm length, BARD, UDI: 00801...
Surgical Devices·1,731 affected·May 31, 2019
High RiskFDA
Bard Peripheral Vascular Inc
GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product code:5397230, 14.5F, straight, 23cm length, BARD, UDI: 00801...
Surgical Devices·899 affected·May 31, 2019
High RiskFDA
Bard Peripheral Vascular Inc
EQUISTREAM LONG-TERM HEMODIALYSIS CATHETER, REF/Product Code:5905190, 14.5 Fr. Alphacurve Catheter with Standard Kit, 19 cm length, BARD,...
Surgical Devices·34 affected·May 31, 2019
High RiskFDA
Bard Peripheral Vascular Inc
GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product code:5397500, 14.5F, straight, 50cm length, BARD, UDI: 00801...
Surgical Devices·140 affected·May 31, 2019
High RiskFDA
Bard Peripheral Vascular Inc
EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5913420, 16F, Straight, 42cm length, BARD, UDI: 00...
Surgical Devices·100 affected·May 31, 2019
High RiskFDA
Bard Peripheral Vascular Inc
GlidePath Long-Term Hemodialysis Catheter, REF/Product code:5396240, 14.5F, Alphacurve, 19cm length, BARD, UDI: 00801741012259
Surgical Devices·570 affected·May 31, 2019
High RiskFDA
Bard Peripheral Vascular Inc
EQUISTREAM LONG-TERM HEMODIALYSIS CATHETER, REF/Product code:5905240, 14.5 Fr. Alphacurve Catheter with Standard Kit, 24cm length, BARD,...
Surgical Devices·135 affected·May 31, 2019
High RiskFDA
Bard Peripheral Vascular Inc
EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5913190, 16F, Straight, 19cm length, BARD, UDI: 00...
Surgical Devices·455 affected·May 31, 2019
High RiskFDA
Bard Peripheral Vascular Inc
EQUISTREAM Long-Term Hemodialysis Catheter with Preloaded Styet, REF/Product code:5904270, 14.5F, Straight ,27cm length, BARD, UDI: 00801...
Surgical Devices·39 affected·May 31, 2019
High RiskFDA
Stonyfield Farm
Strawberry Banana Smoothie, 3.1oz, 6 pack, UPC Code 52159-70082
Beverages·5,148 affected·May 30, 2019
High RiskFDA
Surgery Pharmacy Services Inc
Memorial Central TPN. Rx Only, Rx # specific and Patient Specific volumes. Mixed by Surgery Pharmacy Serv., 3908 TENN.AVE., SUITE F., C...
Drugs·1,149 affected·May 30, 2019
High RiskFDA
Surgery Pharmacy Services Inc
Trisodium Citrate 0.5% CRRT SOLUTION. RX Only. Rx # specific and Patient Specific volumes. Mixed by Surgery Pharmacy Services,3908 TENN.A...
Drugs·84 affected·May 30, 2019
High RiskFDA
Paltop Advanced Dental Solutions Ltd
Paltop Advanced Plus Dental Implant Dia 6.0mm L10mm Catalog Number: 20-70024P
Medical Implants·167 affected·May 30, 2019
High RiskFDA
Ortho Development Corporation
Tibial Tray Nonporous A Size 2; Model # PN 162-1200-A; Material: Ti6Al4V.
Medical Devices·27 affected·May 30, 2019
High RiskFDA
Medline Industries, Inc.
Anti-fog solution packaged in a Tyvek peel pouch and it is placed into various kits. Kit are labeled as follows: ROBOTIC GENERAL, LAP C...
Cardiac Devices·14,550 affected·May 30, 2019
High RiskFDA
Boston Scientific Neuromodulation Corporation
Nitinol Thermocouple Electrode, 5cm - Product Usage: The TCN Electrode is indicated for use in RF heat lesioning of peripheral nerve tiss...
Medical Devices·43 affected·May 30, 2019
High RiskFDA
Clinical Innovations, Llc
Clearview Total Uterine Manipulator (model UM750), The device is labeled in part, "ClearView(R) TOTAL, 7 cm* * *CLINICAL INNOVATIONS Man...
Medical Devices·280 affected·May 30, 2019
High RiskFDA
Zyno Medical Llc
Zyno Medical Administration Set -105"ADMIN SET 20DP W/FILTER 2YSITES CLMP- For Use with Zyno Medical Infusion pumps or Gravity Feed Pr...
Medical Devices·360 affected·May 29, 2019
High RiskFDA
Siemens Healthcare Diagnostics Inc
Stratus CS Acute Care cTNI TestPak, SMN 10445071 Product Usage: In vitro diagnostic test for the measurement of cardiac troponin I in...
Cardiac Devices·2,312 affected·May 29, 2019
High RiskFDA
Nexagen, Llc
ACID RAIN ASS KICKING FAT DESTROYER APOCALYPSE LABZ; 45 CAPSULES; 1 DIETARY SUPPLEMENT; UPC 6 11138 28792 0
Supplements·157 affected·May 28, 2019
High RiskFDA
Synthetopes Inc
Sn-d, l-Exametazime (Sn-d,l-HMPAO), Not for Direct Injection, Store Below 25 C, Synthetopes, Inc.
Injectable Drugs·68 affected·May 28, 2019
High RiskFDA
Synthetopes Inc
Sn-DTPA Kit 10 mg, DTPA, Not for Direct Injection, Store at Room Temperature, Synthetopes, Inc.
Injectable Drugs·82 affected·May 28, 2019
High RiskFDA
Synthetopes Inc
Sn-Tetrofosmin Kit 5.0 mL, Thaw and Vent before use, Not for Direct Injection, Store Frozen, Synthetopes, Inc.
Injectable Drugs·0 affected·May 28, 2019
High RiskFDA
Synthetopes Inc
Sn-Mertiatide Kit,1 milligram betiatide, Not for Direct Injection, Store at Room Temperature, Synthetopes, Inc.
Injectable Drugs·35 affected·May 28, 2019
High RiskFDA
Synthetopes Inc
Sulfur Colloid Reaction Vial 1.0 mL, Thaw Before Use, Not for Direct Injection, Store Frozen, Synthetopes, Inc.
Injectable Drugs·20 affected·May 28, 2019
High RiskFDA
Synthetopes Inc
Sn-Pyrophosphate Kit, 11.9 mg sodium pyrophosphate, Not for Direct Injection, Store at Room Temperature, Synthetopes, Inc.
Injectable Drugs·45 affected·May 28, 2019