2013 Safety Alerts for Human Medical Products

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Drugs and Therapeutic Biological Products

Product Name	Date Issued/Updated
All Sterile Drug Products Made and Distributed By NuVision Pharmacy Dallas Facility: Recall - Lack Of Sterility Assurance	05/18/2013
Sterile Products Compounded, Repackaged, and Distributed by ApothéCure: Recall - Sterility Assurance Concerns	04/16/2013
All Sterile Compounded Products by Nora Apothecary And Alternative Therapies: Recall - Lack of Sterility Assurance	04/23/2013
Lyophilized Products Compounded by NuVision Pharmacy: Recall - Sterility Assurance Concerns	04/16/2013
Avastin Unit Dose Syringes by Clinical Specialties: Recall - Potential For Serious Eye Infection	03/20/2013
Azithromycin (Zithromax or Zmax): Drug Safety Communication - Risk of Potentially Fatal Heart Rhythms	03/12/2013
Balanced Solutions All Sterile Compounded Products: Recall - Lack of Sterility Assurance	04/22/2013
Clinical Specialties Compounding Pharmacy Products: Recall - All Sterile Products Recalled Due To Lack of Sterility Assurance	03/21/2013
Compounded Prescription Therapies By Pentec Health Inc.: Recall - Lack Of Sterility Assurance	05/17/2013
The Compounding Shop: FDA News Release - Lack of Sterility Assurance of Drug Products	05/08/2013
Ferrous Sulfate Tablets, 325 mg Labeled as Rugby Natural Iron Supplement: Recall - Bottle May Contain Meclizine HCl 25 mg Tablets	01/18/2013
Green Valley Drugs: Recall of All Lots of All Sterile Products - Quality Control Concerns	04/11/2013
Incretin Mimetic Drugs for Type 2 Diabetes: Early Communication - Reports of Possible Increased Risk of Pancreatitis and Pre-cancerous Findings of the Pancreas	03/14/2013
Kadcyla (ado-trastuzumab emtansine): Drug Safety Communication - Potential Medication Errors Resulting from Name Confusion	05/06/2013
Lactated Ringers and 5 Percent Dextrose Injection, USP, 1000 ML, Flexible Containers: Recall - Due to Non-Sterility	01/28/2013
Magnesium Sulfate: Drug Safety Communication - Recommendation Against Prolonged Use in Pre-term Labor	05/30/2013
Magnesium Sulfate Injection by Fresenius Kabi USA: Recall - Glass Particles in Vials	05/29/2013
Main Street Family Pharmacy in Tennessee: FDA Alerts Health Care Providers of Adverse Reactions Associated with Steroid Injections	06/13/2013
Med Prep Consulting Inc. Compounded Products: Recall - Potential Mold Contamination	03/18/2013
Methotrexate Sodium, USP Injectable Vials by Sandoz US: Recall - Particulate Matter In Vials	05/21/2013
Olympia Pharmacy Sterile Compounded Products: Recall - Concerns About Sterility Assurance	05/30/2013
Omontys (peginesatide) Injection by Affymax and Takeda: Recall of All Lots - Serious Hypersensitivity Reactions	02/23/2013
Pallimed Solutions, Inc. Sterile Compound Products: Recall - Visible Particulates Observed	03/27/2013
Piperacillin and Tazobactam for Injection, USP 40.5 grams: Recall - Precipitation or Crystallization in IV Bag or IV Line Upon Reconstitution	04/30/2013
Potiga (Ezogabine): Drug Safety Communication - Linked To Retinal Abnormalities And Blue Skin Discoloration	04/26/2013
Samsca (Tolvaptan): Drug Safety Communication - FDA Limits Duration and Usage Due To Possible Liver Injury Leading to Organ Transplant or Death	04/30/2013
Samsca (tolvaptan): Drug Warning - Potential Risk of Liver Injury	01/25/2013
Sensipar (Cinacalcet Hydrochloride): Drug Safety Communication - FDA Suspends Pediatric Clinical Trials After Report Of Death	02/26/2013
Sodium Chloride Injection 0.9 percent USP, 100 mL Flexible Containers by Hospira: Recall - Particulate Matter	04/26/2013
Sodium Chloride Injection, 0.9 percent, 1000 mL, Flexible Container: Recall - Brass Particulates	04/01/2013
Valproate Anti-Seizure Products: Drug Safety Communication - Contraindicated for Pregnant Women for Prevention of Migraine Headaches	05/06/2013
Vecuronium Bromide For Injection by Sagent Pharmaceuticals, Inc.: Recall - Elevated Impurity Result Detected	06/10/2013
Vistide (Cidofovir Injection) by Gilead: Recall - Presence Of Particulate Matter	02/16/2013
Warfarin 2 mg Tablets by Zydus Pharmaceuticals USA Inc.: Recall - Due to Oversized Tablets	06/12/2013
Zolpidem Containing Products: Drug Safety Communication - FDA Requires Lower Recommended Doses	05/14/2013
Zyprexa Relprevv (Olanzapine Pamoate): Drug Safety Communication - FDA Investigating Two Deaths Following Injection	06/18/2013

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Medical Devices

Product Name	Date Issued/Updated
Abbott Diabetes Care: Class 1 Recall - FreeStyle InsuLinx Blood Glucose Meters - Risk of Incorrect Test Result	05/20/2013
Ad-Tech Macro Micro Subdural Electrodes: Class 1 Recall-Potential for Abrasion of Brain	03/07/2013
Animas Corporation 2020 Insulin Infusion Pump: Class I Recall - False Alarm or Warning Sound	04/05/2013
Bausch and Lomb 27G Sterile Cannula Packed in Amvisc and Amvisc Plus Ophthalmic Viscosurgical Devices (OVD): Class I Recall - Cannulas May Leak or Detach From the Syringe	01/23/2013
BCI Remote Alarm Cables By Smith's Medical ASD, Inc.: Class 1 Recall - Cables Are Not Transferring Alarms	04/09/2013
Cardinal Health: Class 1 Recall - Various Presource Kits Containing a Pre-Assembled Anesthesia Circuit	05/07/2013
Cardinal Health: Class 1 Recall - Various Presource Kits Containing a Pre-Assembled Anesthesia Circuit	05/07/2013
CareFusion Alaris PC Unit with Software V9.12: Class 1 Recall - Communication Error When Attached to EtCO2 or SpO2 Modules	04/22/2013
Cook Medical, Inc Zilver PTX Drug-Eluting Peripheral Stent: Class 1 Recall - Complaints of Delivery System Tip Separation	05/24/2013
Covidien Surgical Stapler Reloads: FDA Safety Communication - Devices Stolen Before They Were Sterilized	05/07/2013
Cybersecurity for Medical Devices and Hospital Networks: FDA Safety Communication	06/17/2013
DePuy Orthopaedics LPS Diaphyseal Sleeve: Class I Recall - Taper Connection May Not Accommodate Physiologic Loads	02/22/2013
Endologix, Inc. AFX Introducer System: Class 1 Recall - Reports Of Dilator Breaking During Procedures	06/18/2013
Fisher and Paykel Healthcare Reusable Breathing Circuit: Class I Recall - Pinholes in Tubes	01/07/2013
GE Healthcare, Giraffe OmniBed and Giraffe Incubator: Class I Recall - Device May Randomly Delete Stored Information When Powered On	04/24/2013
GE Healthcare, LLC, Giraffe and Panda T-Piece Resuscitation Systems and Mask Resuscitation Systems: Class 1 Recall - Potential reversal of oxygen/air	02/14/2013
Hospira Inc., GemStar Infusion System: Recall - Lithium Battery Low Voltage	05/01/2013
LifeScan, Inc. OneTouch Verio IQ Blood Glucose Meter – Class I Recall: Failure to Provide a Warning at Extremely High Blood Glucose Levels	04/23/2013
Lumenis VersaCut Tissue Morcellator: Class 1 Recall - Labeling Correction - Potential For Air Embolisms To Occur If Tubing Is Hooked Up Backwards	02/25/2013
Maquet SERVO-i Ventilator Battery Module: Class 1 Recall - Battery Run Time Shorter Than Expected	05/07/2013
Medical Bed Mattresses: FDA Safety Communication - Damaged or Worn Covers Pose Risk of Contamination and Infection	04/19/2013
Medtronic: Class 1 Recall - Medtronic Deep Brain Stimulation Lead Kit and Activa Dystonia HDE Kit	05/07/2013
Nephron Pharmaceuticals Corp. EZ Breathe Atomizer: Class 1 Recall - Washer Could Become Dislodged	06/03/2013
Newport Medical Instruments, Inc., HT70 and HT70 Plus Ventilators: Class I Recall - Unit Goes Into Internal Backup Battery Sooner Than Expected	05/01/2013
Praxair Inc., Grab ‘n Go Vantage Portable Oxygen Cylinder Units: Class I Recall - Risk of Fire Inside Cylinder Unit	01/03/2013
Spacelabs Anesthesia Workstations and Service Kits: Class 1 Recall - Defect in CAS I/II Absorbers	03/26/2013
St. Jude Medical, AMPLATZER TorqVue FX Delivery System: Class I Recall - Core Wire May Fracture	02/13/2013
Stryker Orthopaedics – ShapeMatch Cutting Guide: Class 1 Recall	04/18/2013
Symbios GOPump Elastomeric Infusion PumpKit: Class 1 Recall - Flow Restrictor Bead May Become Displaced from its Fitting	03/18/2013
Symbios GOPump and GOBlock Kits: Class 1 Recall - Potential for Excessive High Flow Rates	06/12/2013
Vascular Solutions Inc., Guardian II and Guardian II NC Hemostasis Valves: Class I Recall - Risk of Air Being Introduced Into Device	03/27/2013
Vycor Viewsite Brain Access System (VBAS): Class 1 Recall - Unidentified Fiber Found on Device	01/30/2013

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Special Nutritional and Cosmetic Products

Product Name	Date Issued/Updated
Atriphen dietary supplement (Xymogen brand): Recall - Potential Allergic Reaction Due to Milk and Soy	05/09/2013
Eba Multivitamin Supplement By Saratoga Therapeutics LLC: Recall - Allergy Alert On Undeclared Milk Components	04/26/2013
Z Pro High Protein Supplement: Recall - Undeclared Soy And Milk	02/04/2013

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Biologics

Product Name	Date Issued/Updated
Anticoagulant Citrate Phosphate Dextrose Solution, USP (CPD) BLOOD-PACK Unit By Fenwal: Recall - Labeling Issue Identified	04/30/2013
BIVIGAM Immune Globulin Intravenous (Human), 10 Percent Liquid, 100 mL Sterile Vial: Recall - Visible Particles Observed	04/05/2013

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Products With Undeclared Drug Ingredients

Product Name	Date Issued/Updated
Affirm XL: Recall - Undeclared Drug Ingredient	04/11/2013
American Lifestyle Vicerex and Black Ant Capsules: Recall - Undeclared Drug Ingredient	05/02/2013
Bullet Proof: Public Notification - Undeclared Drug Ingredient	05/07/2013
Lightning Rod Capsules: Recall - Undeclared Drug Ingredient	05/07/2013
Maxiloss Weight Advanced Softgels: Recall - Undeclared Drug Ingredient	02/25/2013
Night Bullet: Recall - Undeclared Drug Ingredient	03/12/2013
Reumofan Plus: Recall - Undeclared Drug Ingredient	02/19/2013
ROCK-It MAN Male Enhancement Capsules: Recall - Undeclared Drug Ingredient	04/09/2013
SexVoltz, Velextra, and Amerect by Beomonstar Products: Recall - Undeclared Drug Ingredient	05/08/2013
Super Power: Recall - Undeclared Ingredient	01/28/2013

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2013 Safety Alerts for Human Medical Products

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