Medwatch Safety Alert Archive, 2017
MedWatch alerts in chronological order, 2017. For the most recent safety alerts, see "What's New" on the MedWatch home page
MedWatch Safety Alerts, Jan 01 - Dec 31 2017
Potassium Phosphate and Succinylcholine Chloride by PharMEDium Services: Recall - Lack of Sterility Assurance Reasonable probability that the patient may experience adverse events ranging from fever, chills and malaise, to severe adverse events including systemic invasive mycoses or systemic bacterial sepsis. Posted 06/27/2017 Succinylcholine Chloride 20mg/mL 5mL Syringe by Fagron Sterile Services: Recall - Potential Lack Of Sterility Assurance Reasonable probability that patient may experience adverse events ranging from fever, chills and malaise, to severe adverse events including systemic invasive mycoses or systemic bacterial sepsis. Posted 06/23/2017 Venture Catheters by Vascular Solutions: Recall - Excess Material May Split or Separate During Use UPDATED 06/23/2017. All unexpired lots of the RX, OTW, and CS versions are recalled. Material in the patient's bloodstream can result in serious adverse health consequences such as the development of blood clots, embolism of the excess material to... Potassium Phosphate and Succinylcholine by Advanced Pharma: Recall - Potential Lack of Sterility Assurance Patient may experience adverse events ranging from fever, chills and malaise, to severe adverse events including systemic invasive mycoses or systemic bacterial sepsis. Posted 06/22/2017 System CS100, CS100i and CS300 Intra-Aortic Balloon Pumps by Datascope: Field Correction - Potential Electrical Test Failure Code Report of failure of the device to initiate therapy. Posted 06/19/2017 Clindamycin Injection ADD-Vantage Vials by Alvogen: Recall - Lack of Sterility Assurance There is a reasonable probability that the patient may experience adverse events, ranging from fever, chills and malaise, to severe adverse events including systemic invasive mycoses or systemic bacterial sepsis. Posted 06/16/2017 Sodium Bicarbonate Injection 8.4 Percent USP, Neut (Sodium Bicarbonate 4 Percent Additive Solution), Quelicin (Succinylcholine Chloride Injection USP), and Potassium Phosphates Injection by Hospira: Recall - Potential For Lack Of Sterility Assurance A patient may experience adverse events ranging from fever, chills and malaise, to severe adverse events including systemic invasive mycoses or systemic bacterial sepsis. Posted 06/16/2017 Unexpired Nitroglycerin Injection in 5 Percent Dextrose USP by Advanced Pharma in Houston: Recall - Sub Potency An extreme and unexpected reduction in dose than expected could lead to a delay in treatment, disruption of clinical care of the patient, and worsening of patient’s conditions. Posted 06/15/2017 Paliperidone Extended-Release Tablets 3mg by Teva Pharmaceuticals: Recall - Dissolution Test Failure Failed dissolution could result in less drug being absorbed. Posted 06/15/2017 Frameless Stereotaxic Navigation Systems: FDA Safety Communication - Navigational Accuracy Errors Accuracy errors may lead to patient deaths, serious or life-threatening injuries, and inaccurate, aborted, or prolonged medical procedures. Posted 06/15/2017 Topical Products by Phillips Company: Recall - Due to Concerns of Manufacturing Practices The possibility of decreased quality and consistency of the product, may have an impact on the safety and efficacy of the product posing a risk to patients. Posted 06/14/2017 Eliquis (apixaban) 5 mg tablets: Recall One Lot- Bottle labeled as Eliquis 5 mg was found to contain Eliquis 2.5 mg tablets Patients should not stop taking Eliquis without consulting with their physician. Posted 06/13/2017. LeadCare Testing Systems (with Blood Obtained from a Vein) by Magellan Diagnostics: FDA Safety Communication - Risk of Inaccurate Results UPDATED 07/13/2017. Statement from FDA on the status of the investigation into inaccurate results from certain lead tests, including release of inspection report. Originally posted 05/17/2017 SpF PLUS-Mini and SpF XL IIB Implantable Spinal Fusion Stimulators by Zimmer Biomet: Class I Recall - Potential for Harmful Chemicals Higher than allowed levels of harmful chemicals may cause chronic infections, long-term hospitalization due to additional surgical procedures, paralysis, and death. Posted 05/30/2017 Mibela 24 Fe Chewable Tablets by Lupin Pharmaceuticals Inc.: Recall - Out of Sequence Tablets and Missing Expiry/Lot Information Oral contraceptive tablets that are taken out of sequence may place the user at risk for contraceptive failure and unintended pregnancy. Posted 05/29/2017 Brilinta (ticagrelor) 90 mg tablets, 8-count Physician Sample Bottles: Recall of Lot # JB5047 - Due to Report of Another Medicine in One Bottle Unintentional dosing with Zurampic has the potential to lead to adverse renal effects including acute renal failure. Posted 05/26/2017 Caverflo Natural Herbal Coffee: Recall - Presence of Undeclared Active Pharmaceutical Ingredients Presence of sildenafil and tadalafil may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels. Posted 05/26/2017 Al-Er-G Capsules by MusclMasster: Recall - Contains Banned Substance Ephedra Dietary supplements containing ephedrine alkaloids pose a risk of serious adverse events, including heart attack, stroke, and death. Posted 05/25/2017 HeartMate II LVAS Pocket System Controller by Abbott-Thoratec: Class I Recall - Due to Risk of Patient Injury and/or Death during Backup Controller Exchange A slow or improper driveline changeover places certain patients at risk of serious injury or death. Posted 05/23/2017 Tri-Ton by Dynamic Technical Formulations, LLC: Recall - Contains Andarine and Ostarine Drug Ingredients Use or consumption of products containing SARMs and anabolic steroid-like substances may cause acute liver injury, which is known to be a possible harmful effect of using steroid containing products. Posted 05/22/2017 V60 Non-invasive Ventilator by Respironics: Class I Recall - Unexpected Device Shut Down Unexpected stop in ventilation therapy may cause serious adverse health consequences, including death. Posted 05/22/2017 Gadolinium-based Contrast Agents for Magnetic Resonance Imaging (MRI): Drug Safety Communication - No Harmful Effects Identified With Brain Retention Health care professionals should continue to limit GBCA use to circumstances in which additional information provided by the contrast agent is necessary, and assess the necessity of repetitive MRIs with GBCAs. Posted 05/22/2017 Wingman35 Crossing Catheters by ReFlow Medical: Recall - Tip Splitting or Separation UPDATED 05/17/2017 Recall classified as class I. Tip splitting has the potential to lead to loss of device function. Tip separation may require medical intervention to retrieve a separated segment or may occlude blood flow to end organs. Posted 05/03/2017 Coronary Catheters by Abbott: Recall - Difficulty in Removing Balloon Sheath Potential risks associated with balloon inflation and deflation difficulties include air embolism, additional intervention, thrombosis, and myocardial infarction. Posted 05/16/2017 Canagliflozin (Invokana, Invokamet): Drug Safety Communication - Increased Risk of Leg and Foot Amputations New warnings, including a Boxed Warning, to be added to the canagliflozin drug labels. Posted 05/16/2017 Phenobarbital 15 mg Tablets, USP by C.O. Truxton: Recall - Labeling Error on Declared Strength UPDATED 05/08/2017. C.O. Truxton expands recall of Amitriptyline HCL Tablets and Phenobarbital Tablets, due to potential label mix-up. Originally posted 04/21/2017 GEC Laxoplex Dietary Supplement Capsules by Genetic Edge Compounds: Recall - Presence of Anabolic Steroids Use or consumption of products containing anabolic steroids may cause acute liver injury. Abuse of anabolic steroids may cause other serious long-term adverse health consequences in men, women, and children. Posted 05/08/2017 HeartWare Splice Kit Intended to Repair the Driveline of its Ventricular Assist Device by Medtronic: Recall - May Cause Electrical Issues or Pump Stops An interruption in electrical connection may cause the pump to stop, which may lead to serious adverse health consequences, including death. Posted 05/05/2017 Ventricular Assist Device Controllers and DC Adapter by Medtronic Mechanical Circulatory Support (formerly HeartWare Inc.): Class I Recall - Updated Controller, Power Management Software Loose connector may allow moisture to enter controller causing corrosion, electrical issues, reduced speaker volume and connection failures which could cause serious adverse health consequences, including death. Posted 05/04/2017 Wingman35 Crossing Catheters by ReFlow Medical: Recall - Tip Splitting or Separation UPDATED 05/17/2017 Recall classified as class I. Tip splitting has the potential to lead to loss of device function. Tip separation may require medical intervention to retrieve a separated segment or may occlude blood flow to end organs. Posted 05/03/2017 NavLock Tracker by Medtronic: Letter to Healthcare Providers - Patient Injuries Reported Minor and serious injuries, including two patient deaths, following procedures that involved the use of non-Medtronic instruments with Medtronic's NavLock Tracker. Posted 05/03/2017 General Anesthetic and Sedation Drugs: Drug Safety Communication - FDA Approves Label Changes for Use in Young Children Exposure to these medicines for lengthy periods of time or over multiple surgeries or procedures may negatively affect brain development in children younger than 3 years. Posted 04/27/2017 Illegal Cancer Treatments: FDA Warning - Fraudulent Claims of Diagnosis, Treatment, Prevention or Cure Use of unproven or unapproved products may be unsafe and could prevent a person from seeking an appropriate and potentially life-saving cancer diagnosis or treatment. Posted 04/25/2017 25 Percent Dextrose Injection, USP (Infant) by Hospira: Recall - Particulate Matter Particulate administered to a patient could result in local swelling, irritation of blood vessels or tissue, blockage of blood vessels and/or systemic allergic response to the particulate. Posted 04/24/2017 Phenobarbital 15 mg Tablets, USP by C.O. Truxton: Recall - Labeling Error on Declared Strength UPDATED 05/08/2017. C.O. Truxton expands recall of Amitriptyline HCL Tablets and Phenobarbital Tablets, due to potential label mix-up. Originally posted 04/21/2017 Codeine and Tramadol Medicines: Drug Safety Communication - Restricting Use in Children, Recommending Against Use in Breastfeeding Women New and strengthened WARNINGS and CONTRAINDICATIONS on drug labels describing serious risks, including slowed or difficult breathing and death. Posted 04/20/2017 Organic Herbal Supply Supplement Products: Recall - Undeclared Drug Ingredients Use of these products may pose a threat to consumers because the undeclared ingredients may interact with nitrates found in some prescription drugs and may lower blood pressure to dangerous levels. Posted 04/19/2017 Certain Homeopathic Teething Products: Recall - Confirmed Elevated Levels of Belladonna Updated 04/13/2017. Homeopathic teething products containing belladonna pose an unnecessary risk to infants and children. Originally posted 01/27/2017 StrataMR Adjustable Valves and Shunts by Medtronic: Recall - Potential for Under-Drainage of Cerebrospinal Fluid If left untreated, under-drainage can potentially lead to coma and death. Posted 04/08/2017 Sterile Compounded Products by Isomeric Pharmacy Solutions: Recall - Lack of Sterility Assurance Voluntary recall of all lots of sterile products, to the hospital/user level. Posted 04/06/2017 Newport HT70 and HT70 Plus Ventilators by Medtronic: Field Corrective Action - Ventilator May Reset Spontaneously UPDATED 05/02/2017. Class I Recall. Potential for ventilator reset during normal operation, without an accompanying alarm. Originally posted 04/05/2017 EpiPen and EpiPen Jr Auto-Injector: Recall - Failure to Activate Device Failure to activate or increased force needed to activate may have significant health consequences for a patient experiencing a life-threatening allergic reaction (anaphylaxis). Posted 03/31/2017 Prelude Short Sheath Introducer by Merit Medical Systems: Class I Recall - Sheath May Separate During Use Tip could enter the patient's bloodstream, resulting in prolonged procedure times, additional surgery to remove the tip from the patient, blood clots, internal tears and perforation to arteries or veins, excessive bleeding, and death. Posted 03/31/2017 LaBri’s Body Health Atomic by Envy Me: Recall - Undeclared Drug Ingredient Sibutramine may substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. Posted 03/30/2017 HeartStart MRx Monitor/Defibrillator by Phillips Healthcare: Class I Recall - Electrical Issues A delay in delivering therapy could result in serious patient injury such as permanent organ damage, brain injury, or death. Posted 03/24/2017 Breast Implants: Update - Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) BIA-ALCL is a rare condition; when it occurs, it has been identified most frequently in patients undergoing implant revision operations for late onset, persistent seroma. Posted 03/21/2017 Absorb GT1 Bioresorbable Vascular Scaffold (BVS) by Abbott Vascular: Letter to Health Care Providers - FDA Investigating Increased Rate of Major Adverse Cardiac Events Increased rate of major adverse cardiac events observed in patients receiving the BVS, when compared to patients treated with metallic XIENCE drug-eluting stent. Posted 03/18/2017 Viberzi (eluxadoline): Drug Safety Communication - Increased Risk of Serious Pancreatitis In Patients Without A Gallbladder Patients who do not have a gallbladder should not take Viberzi. Developing pancreatitis could result in hospitalization or death. Posted 03/15/2017 SynchroMed II and SynchroMed EL Implantable Drug Infusion Pumps by Medtronic: Class I Recall - Failure of Priming Bolus Patients may receive a drug overdose or under dose which can lead to serious adverse health consequences such as respiratory depression, coma or death. Posted 03/14/2017 Herbal and Dietary Supplement Products by Regeneca Worldwide: Recall - Not Manufactured in Compliance with Current Good Manufacturing Practices Nationwide recall of Regeneca's entire line of herbal and dietary supplement products. Posted 03/09/2017 SPS-1 Static Preservation Solution distributed by Organ Recovery Systems: Safety Communication - FDA Warns Of Potential Contamination Laboratory results confirmed contamination with Pantoea and Enterococcus (intrinsically vancomycin-resistant) bacteria. Posted 03/09/2017 Balloon angioplasty devices to treat autonomic dysfunction: FDA Safety Communication - FDA concern over experimental procedures Procedure may put patients at risk because is being promoted as treatment for a variety of conditions even though it has not been formally studied in clinical trials. Posted 03/08/2017 Dietary Supplements for Male Sexual Enhancement by A and H Focal: Recall - Undeclared Drug Ingredient PDE-5 Inhibitors may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Posted 03/07/2017 Edex (alprostadil for injection) 10 mcg 2 Pack by Endo Pharmaceuticals: Recall - Potential Lack of Sterility Assurance Loss of container closure integrity could impact the product’s sterility assurance and may lead to serious adverse events such as infections, both localized at the site of injection and systemically. Posted 02/27/2017 Avella Specialty Pharmacy Unexpired Sterile Injectable Products Labeled “Latex Free”: Recall - Products May Contain Synthetic or Natural Latex Risk of potential adverse events can range from local site reactions including swelling and inflammation, to allergic reactions which could be life-threatening to users who are sensitive to latex. Posted 02/24/2017 XtraHRD Natural Male Enhancement Capsules by Organic Herbal Supply, Inc.: Recall - Undeclared Drug Ingredient Undeclared tadalafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Posted 02/22/2017 Comprehensive Reverse Shoulder by Zimmer Biomet: Class I Recall - High Fracture Rate Fractures may result in revision surgeries which could cause serious adverse health consequences such as permanent loss of shoulder function, infection, or rarely, death. Posted 02/16/2017 HCG (Human Chorionic Gonadotropin) Freeze Dried Vials by Synergy Rx: Recall - Lack of Sterility Assurance Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening. Posted 02/15/2017 Alaris Syringe Pump Module (Large Volume Pump), Model 8100 and AIL Sensor Kits by CareFusion: Class I Recall - Alarm Error Faulty Air-In-Line sensor which may generate a false alarm, and cause the syringe pump to stop supplying the infusion to the patient. Interruption of infusion could lead to serious adverse health consequences or death. Posted 02/09/2017 Ibuprofen Lysine Injection, 20 mg /2 mL (10 mg/mL) by Exela Pharma Sciences: Recall - Particulate Matter Particulate matter has the potential to block blood vessels, provoke an immune reaction, and/or lead to microinfarcts which could be life threatening. Posted 02/09/2017 Well Balance Xanthium & Siler Combo (Bi Yan Pian) Dietary Supplement by Kingsway Trading Inc.: Recall - Product Contains Banned Ephedra Alkaloids Supplements containing ephedrine alkaloids pose a risk of serious adverse events, including heart attack, stroke, and death. Posted 02/09/2017 Chlorhexidine Gluconate: Drug Safety Communication - Rare But Serious Allergic Reactions Reactions can occur within minutes of exposure, and may include wheezing or difficulty breathing; swelling of the face; hives that can quickly progress to more serious symptoms; severe rash; or shock, a life-threatening condition. Posted 02/02/2017 Halo One Thin-Walled Guiding Sheath by Bard Peripheral Vascular Inc.: Class I Recall - Sheath Separation, Kinking, or Tip Damage The affected product may cause serious adverse health consequences such as internal tears and perforation to arteries or veins, excessive bleeding, and death. Posted 01/30/2017 Certain Homeopathic Teething Products: Recall - Confirmed Elevated Levels of Belladonna Updated 04/13/2017. Homeopathic teething products containing belladonna pose an unnecessary risk to infants and children. Originally posted 01/27/2017 NucliSENS easyMAG Magnetic Silica and NucliSENS Magnetic Extraction Reagents by bioMerieux: Class I Recall - Potential Inaccurate Test Results Risk of false negative results, invalid results, or under-quantification for clinical laboratory tests. This error may result in inappropriate treatment or delay in treatment. Posted 01/27/2017 Vancomycin Hydrochloride for Injection, USP by Hospira: Recall - Particulate Matter in Vial Injected particulate may result in local swelling, irritation of blood vessels or tissue, blockage of blood vessels and/or low-level allergic response to the particulate. Posted 01/25/2017 ED-3490TK Video Duodenoscope by Pentax: FDA Safety Communication - UPDATE - Follow Pentax Validated Reprocessing Instructions Updated recommendations to help prevent the spread of infection associated with the use of these devices. Posted 01/17/2017 Lifepak 1000 Defibrillators by Physio-Control: Voluntary Field Action - Immediately Remove and Reinstall Battery Device has shut down unexpectedly during patient treatment, which may expose patients to the risk of serious harm or death. Posted 01/14/2017 Duodenoscopes by Fujifilm Medical Systems: Safety Communication - Certain Older Models Removed From Clinical Use Fuji removing legacy 250/450 duodenoscope models from clinical use, replacing with with the ED-530XT model. Posted 01/13/2017 PNC-27 Products: FDA Warning – Do Not Use For Treatment or Cure for Cancer Consumers who use a contaminated product are at risk for serious, potentially life-threatening infections. Posted 01/12/2017 Medrad Intego PET Infusion System Source Administration Sets by Bayer: Corrective Action - Particulates Generated in Vial The particulate matter could enter into the patient and cause serious adverse health consequences including infection, damage of tissue, and death. Posted 01/11/2017 Implantable Infusion Pumps in the Magnetic Resonance (MR) Environment: FDA Safety Communication - Important Safety Precautions Reports of serious adverse events, including patient injury & death, describing medication dosing inaccuracies and other mechanical problems with pumps after an MRI exam. Posted 01/11/2016 Implantable Cardiac Devices and Merlin@home Transmitter by St. Jude Medical: FDA Safety Communication - Cybersecurity Vulnerabilities Identified These vulnerabilities, if exploited, could allow an unauthorized user to remotely access a patient's RF-enabled implanted cardiac device by altering the Merlin@home Transmitter. Posted 01/09/2017 I.V. Flush Syringes by Nurse Assist: Recall - Potential Link to Burkholderia Cepacia Bloodstream Infections UPDATED 01/04/2017 Recall classified as Class I. The effects of Burkholderia cepacia on people vary widely, ranging from no symptoms at all to serious respiratory infections, especially in patients with cystic fibrosis. Originally Posted 10/05/2016