Medwatch Safety Alert Archive, 2018
MedWatch alerts in chronological order, 2018. For the most recent safety alerts, see "What's New" on the MedWatch home page
MedWatch Safety Alerts, Jan 01 - Dec 31 2018
Fluticasone Propionate Nasal Spray by Apotex Corp: Recall - Due to Potential for Small Glass Particles The glass particles could block the actuator and impact the functionality of the pump and expose patients to the glass particles.[Posted 05/31/2018] TAYTULLA (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules) by Allergan: Recall - Due to Out of Sequence Capsules As a result of this packaging error, oral contraceptive capsules, that are taken out of sequence, may place the user at risk for contraceptive failure and unintended pregnancy. [Posted 05/29/2018] X-Jow and Acne Shave Products by Shadow Holdings: Voluntary Recall - Due to Possible Bacterial Contamination Topical administration of the products could result in potentially serious bacterial infections in immunocompromised individuals. [Posted 05/29/2018] 95% Ethyl Alcohol Product by Ethanol Extraction: Recall - Due to a Possible Contamination with Methanol Methanol,a highly toxic type of alcohol, can cause serious and sometimes fatal damage if ingested by humans or animals. [Posted 05/24/2018] Oral Over-the-Counter Benzocaine Products: Drug Safety Communication - Risk of Serious and Potentially Fatal Blood Disorder Oral OTC benzocaine products should not be used to treat infants and children younger than 2 years and should only be used in adults and children 2 years and older if they contain certain warnings on the drug label. [Posted 05/23/2018] HeartMate 3™ Left Ventricular Assist System: Class I Recall - Due to Potential Malfunction that may Lead to Graft Occlusion that can reduce or stop pump flow and set off a persistent low flow alarm in the system and can lead to blood clots and death.[05/22/2018] Homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir by MBI Distributing: Recall - Due to a Lack of Adequate Controls Manufacturing products without proper process controls increases the probability that products will vary in strength, quality and purity. [Posted 05/21/2018] Keytruda (pembrolizumab) or Tecentriq (atezolizumab): FDA Alerts Health Care Professionals and Investigators: FDA Statement - Decreased Survival in Some Patients in Clinical Trials Associated with Monotherapy Early reviews found patients in the monotherapy arms of both trials with PD-L1 low status had decreased survival compared to patients who received cisplatin- or carboplatin-based chemotherapy. Posted 05/18/2018 7K and Poseidon 4500 by Shoreside Enterprises: Voluntary Recall - Due to Presence of Undeclared Sildenafil and/or Tadalafil Use of product may pose a threat to consumers because the active ingredient may interact with nitrates found in some prescription drugs[Posted 05/18/2018]. Juluca, Tivicay, Triumeq (dolutegravir): FDA to Evaluate - Potential Risk of Neural Tube Birth Defects found that women who received dolutegravir at the time of becoming pregnant or early in the first trimester appear to be at higher risk for these defects [Posted 05/18/2018]. MindFrame Capture LP Revascularization Device by Medtronic: Class I Recall - Due to Wire Material That May Break or Separate During Use The clot retriever could be left inside the patient's bloodstream and can lead to further complications[Posted 05/18/2018]. Medline Remedy Essentials No-Rinse Cleansing Foam: Avoid Using - Multistate Outbreak of Burkholderia Cepacia Complex reports that there are 10 confirmed cases linked to the Medline product, Remedy Essentials No-Rinse Cleansing Foam. [Posted 05/10/2018] Lamictal (lamotrigine): Drug Safety Communication - Serious Immune System Reaction FDA is requiring a new warning about this risk be added to the prescribing information in the lamotrigine drug labels. [Posted 04/25/2018] Dietary Supplements by Nutrizone: Recall - Potential for Salmonella Contamination Expanded recall of various kratom dietary supplements to additional lot numbers due to possible Salmonella Health Risk. Posted 04/20/2018 NxtGen Botanicals Maeng Da Kratom by NGB Corp.: Recall - Possible Salmonella Contamination The recall was initiated after NGB Corp. was notified of positive Salmonella test results by FDA. Posted 04/19/2018 Certain Kratom-Containing Powder Products by Viable Solutions: Recall -Possible Salmonella Contamination an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Posted 04/19/2018 Vyaire Medical AirLife Resuscitation Device & Broselow Convenience Kit by Vyaire Medical: Class I Recall - Due to Risk of Malfunction Caused by Error in Product Design that may result in difficultly or the inability to disconnect the mask from the elbow of the resuscitator. [Posted 05/11/2018] Ampicillin and Sulbactam for Injection USP, 3 g Single-Dose Vials by AuroMedics Pharma: Recall - Presence of Red Particulate Matter Ampicillin and Sulbactam for Injection USP, 3 g/Single-Dose Vials by AuroMedics Pharma: Recall - Exposure to particulate may result in local site reaction, thromboembolic events and systemic immune response. Posted 05/08/2018 Neurovascular Stents Used for Stent-Assisted Coiling (SAC): Letter to Health Care Providers - Recommendations Associated With the Use of These Devices in the Treatment of Unruptured Brain Aneurysms FDA received reports associated with the use of these devices suggest some events of peri-procedural stroke and/or death.[Posted 05/08/2018] 24-Hour Multi-Patient Use Endoscope Connectors: Letter to HealthCare Providers and Healthcare Facilities - Risk of Cross-Contamination FDA is alerting health care providers and facilities about the risk of cross-contamination with certain connectors that are used in gastrointestinal endoscopy. Posted on 04/18/2018 Rhino 69 Extreme 50000 by AMA Wholesale: Recall - Presence of Tadalafil Consumers with diabetes, hypertension, high cholesterol or heart disease often take nitrates; concomitant use of nitrates and PDE5 inhibitors can lead to fatal cardiovascular collapse. Posted 04/18/2018 Fabius Anesthesia Machines by Dräger Medical: Class I Recall - Due to Production Step Error excessive oil was not removed at the time of production and may interfere with the position detector of the ventilation motor and may cause ventilation to fail.[Posted 05/09/2018] Euphoric Capsules by Epic Products: Recall - Undeclared Sildenafil and Tadalafil Consumers with diabetes, hypertension, high cholesterol or heart disease often take nitrates; concomitant use of nitrates and PDE-5 inhibitors can lead to fatal cardiovascular collapse. Posted 04/18/2018 Certain Implantable Cardiac Devices by Abbott (formerly St. Jude Medical): FDA Safety Communication - Battery Performance Alert and Cybersecurity Firmware Updates If the battery runs out, the ICD or CRT-D will be unable to deliver life-saving pacing or shocks, which could lead to patient death. Posted 04/17/2018 Coastal Meds to Recall All Products Marketed as Sterile due to visible particles in some of the drug vials for injection. Posted 4/13/2018 Piperacillin and Tazobactam for Injection, USP 3.375 g Vials by AuroMedics Pharma: Recall - Vials Contain Particulate Matter Piperacillin and Tazobactam for Injection, USP 3.375 g by AuroMedics Pharma: Recall - Exposure to particulate matter may result in local irritation/swelling or more serious outcomes. Posted 05/08/2018 Acrodose PLus and PL Systems by Haemonetics: Recall - Low pH Readings for Platelets Stored in CLX HP Bag Platelets with pH lower than 6.2 and a lack of “swirl” may not be viable. Transfusion of these platelets may lead to delayed correction of coagulopathy or low quality prophylactic platelet transfusion. Posted 04/13/2018 Sterile Injectable Products by Premier Pharmacy Labs: Recall - Lack of Sterility Assurance Administration of non-sterile injection products that are intended to be sterile may result in a site-specific or systemic infection. Posted 04/12/2018 System 83 Plus Automated Endoscope Reprocessors (AERs) by Custom Ultrasonics: FDA Safety Communication - Completed Validation Testing System 83 Plus AERs may now be used to reprocess only the Olympus TJF-Q180V duodenoscope and the Pentax ED-3490TK duodenoscope. Posted 04/10/2018 Maeng Da Red Powder and Capsules by Club 13: Recall - Possible Contamination With Salmonella Salmonella can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Posted 04/10/2018 Essure Permanent Birth Control System by Bayer Healthcare: Announcement - FDA Restricts the Sale and Distribution Sales restricted to only doctors and healthcare facilities who use the FDA-approved “Patient-Doctor Discussion Checklist – Acceptance of Risk and Informed Decision Acknowledgement”. Posted 04/09/2018 Dietary Supplements by Nutrizone: Recall - Potential for Salmonella Contamination Expanded recall of various kratom dietary supplements to additional lot numbers due to possible Salmonella Health Risk. Posted 04/20/2018 Kratom-containing Products by Triangle Pharmanaturals: Mandatory Recall - Risk of Salmonella Salmonella bacteria can cause the foodborne illness salmonellosis. Most people infected with salmonella develop diarrhea, fever and abdominal cramps 12 to 72 hours after infection. Posted 04/03/2018 Pasta De Lassar Andromaco Skin Protectant 25 Percent Zinc Oxide by MarcasUSA: Recall - Potential Contamination Use of the contaminated product could result in an increased risk of infection. Posted 04/02/2018 Eclipse Kratom by Tamarack: Recall - Possible Salmonella Contamination Salmonella can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Posted 03/26/2018 BD Vacutainer Blood Collection Tubes by Becton, Dickinson and Company (BD): Class I Recall - Chemical Interference with Certain Tests Falsely lower test results may lead to improper patient management and treatment for lead exposure or poisoning. Posted 03/23/2018 Kratom-containing Powder Products by PDX Aromatics: Recall - Potential for Contamination with Salmonella UPDATED 03/23/2018. Recall expanded to include additional lots. Salmonella contamination can cause serious and sometimes fatal infections in young children, frail or elderly people. Originally posted 03/12/2018 NeuroBlate Probe by Monteris Medical: Letter to Health Care Providers, Class I Recall - Unintended Heating Instances of unintended heating and damage to the probe, which may have resulted in unintended damage to surrounding brain tissue. Posted 03/22/2018 Alka-Seltzer Plus Products: Recall - Ingredients on Front Sticker May Not Match Product in Carton Consumers may ingest a product to which they may have an allergy or anaphylactic reaction, an ingredient which may be contraindicated for their condition or they intend to otherwise avoid, with potential for serious health consequences. Posted 03/16/2018 Neurovascular Embolization Coils: Healthcare Provider Letter - Potential for Increased Image Artifact When Using Magnetic Resonance Angiography For Follow-Up Reduced quality of MRA image from increased artifact can result in inaccurate clinical diagnoses (e.g., occlusion status) and subsequent inappropriate medical decisions. Posted 03/12/2018 Methylprednisolone Sodium Succinate for Injection 40mg, 125mg, and 1g by Sagent Pharmaceuticals: Recall - High Out of Specification Impurity Results An elevated impurity has the potential to decrease effectiveness of the product in patients. Posted: 03/06/2018 Hydromorphone HCL Injection USP by Hospira: Recall - Potential For Empty Or Cracked Glass Vials Use of or exposure to cracked units may be associated with adverse events such as sharps injury to healthcare professionals. Posted 03/05/2018 Compounded Drug Products from Cantrell Drug Company: FDA Warning - Serious Deficiencies in Quality and Sterility Assurance Administration of contaminated or otherwise poor quality drug products can result in serious and life-threatening injury or death. Posted 03/02/2018 Bella Diet Capsules by Bella All Natural: Recall - Presence of Sibutramine Sibutramine and its active metabolites substantially increase blood pressure and/or pulse rate in some patients and may present significant health risks including heart attack, arrhythmia, and stroke. Posted 02/27/2018 Cardiac Resynchronization Therapy with Defibrillation (CRT-Ds) and Implantable Cardiovert-Defibrillators (ICDs) by Medtronic: Class I Recall- Manufacturing Error Preventing Electrical Shock Delivery Delay or inability to deliver a shock to a patient in cardiac arrest or pace a patient’s heart whose heartbeat is too slow could result in serious injury and/or death. Posted 02/27/2018 Labetalol Hydrochloride Injection by Hospira: Recall - Potential For Cracked Glass At Rim Surface Of Vials Cracked vials may result in a lack of sterility assurance. Use of or exposure to a non-sterile product may be associated with adverse events such as fever, chills, sepsis or invasive systemic infections in patients. Posted 02/23/2018 Clarithromycin (Biaxin): Drug Safety Communication - Potential Increased Risk of Heart Problems or Death in Patients With Heart Disease Prescribers advised to consider using other antibiotics in patients with heart disease. Posted 02/22/2018 Acyclovir 400mg Tablets by Apace Packaging: Recall - Product Mix-up Missing a dose of Acyclovir Tablets could cause a reactivation of a virus being treated. Posted 02/13/2018 HeartStart MRx Defibrillator by Philips Electronics: Class I Recall - Defects in Gas Discharge Tubes May Cause Device Failure Continued use of the device in AED mode after failure may lead to serious patient injury or death. Posted 02/09/2018 Pentax Medical Duodenoscope Model ED-3490TK: FDA Safety Communication - Updated Design and Labeling Cleared Design changes are intended to reduce the potential for leakage of patient fluids into the closed elevator channel and under the distal cap. Posted 02/07/2018 Extracorporeal Photopheresis (ECP) Treatment : Letter to Health Care Providers - Death and Pulmonary Embolism FDA has received seven reports of patients experiencing PE during, or soon after, a treatment. Posted 02/05/2018 Gericare Eye Wash by Kareway Products: Recall - Potential Product Contamination Probability of a potentially sight threatening eye infection or impairment. Posted 02/02/2018 Ocaliva (obeticholic acid): Drug Safety Communication - Boxed Warning Added To Highlight Correct Dosing FDA is clarifying the current recommendations for screening, dosing, monitoring, and managing PBC patients with moderate to severe liver disease taking Ocaliva. Posted 02/01/2018 AirLife Humidification Chamber, Heated Breathing Circuit Kits by Vyaire Medical: Class I Recall - Manufacturing Error Parts of the chamber may split apart into layers, allowing water to overflow the chamber and back up into the patient breathing circuit, which could lead to serious adverse health consequences, including injury or death. Posted 01/31/2018 Imodium (loperamide) for Over-the-Counter Use: Drug Safety Communication - FDA Limits Packaging To Encourage Safe Use Reports of serious heart problems and deaths with much higher than recommended doses of loperamide. FDA working with manufacturers to use blister packs or other single dose packaging and to limit number of doses in a package. Posted 01/30/2018 Arthri-D 120ct Dietary Supplement by Arthri-D: Recall - Possible Salmonella Contamination Salmonella can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Posted 01/24/2018 "Zero For Him" Dietary Supplement by Break Ventures/California Basics: Recall - Possible Salmonella Contamination Salmonella can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Posted 01/24/2018 Multiple Drug Products by Flawless Beauty: Recall - Misbranded or Unapproved Misbranded or unapproved new drugs present serious public health risks. Posted 01/22/2018 Basic Drugs Brand of Senna Laxative by Magno-Humphries Laboratories: Recall - Mislabeling Unintentional consumption of naproxen sodium potentially could result in fatal adverse events in patients with underlying illnesses. Posted 01/22/2018 Levofloxacin in 5 Percent Dextrose 250mg/50mL by AuroMedics: Recall - Presence of Visible Particulate Matter Use of a non-sterile injectable product could result in fatal infections. Posted 01/18/2018 Zoll LifeVest 4000 Wearable Cardioverter Defibrillator: FDA Safety Communication - Potential Lack of Treatment (Shock) Delivery Due to Device Failure Failure to immediately replace the device after Message Code 102 appears may result in serious patient harm or death of the patient because the device may fail to deliver therapy when needed. Posted 01/17/2018 Varubi (rolapitant) Injectable Emulsion: Health Care Provider Letter - Anaphylaxis and Other Serious Hypersensitivity Reactions Symptoms of anaphylaxis can include wheezing or difficulty breathing; swelling of the face or throat; hives or flushing; itching; abdominal cramping, abdominal pain or vomiting; back pain or chest pain; hypotension or shock. Posted 01/16/2018 Feeding Tube Placement Systems: Letter to Health Care Providers - Reports of Pneumothorax Events CORRECTION to January 11, 2018 letter. Reported pulmonary events required urgent intervention, including needle decompression or chest tube placement. Posted 01/12/2018 Becton-Dickinson (BD) Syringes Used to Store Compounded or Repackaged Drugs: FDA Alert - Problematic Rubber Stoppers Replaced General use BD syringes are cleared for immediate use in fluid aspiration and injection, but not for use as a closed container storage system for drug products. Posted 01/12/2018 Prescription Opioid Cough and Cold Medicines: Drug Safety Communication - FDA Requires Labeling Changes Risks of slowed or difficult breathing, misuse, abuse, addiction, overdose, and death with these medicines outweigh their benefits in patients younger than 18. Posted 01/11/2018 Certitude Delivery System by Edwards Lifesciences: Class I Recall - Mold Overflow Defect Which May Obstruct Blood Flow Embolism could obstruct blood flow to critical organs, leading to serious injury and/or need to surgically extract overflow material from the patient. Severe neurologic, cardiac, limb, renal, or gastrointestinal injury may result. Posted 01/11/2018 Clopidogrel Tablets USP, 75 mg by International Laboratories: Recall - Product Mislabeling Missed doses of Clopidogrel increases the risk of heart attack and stroke which can be life threatening. Posted 01/10/2018 Ampicillin and Sulbactam for Injection USP 1.5 g/vial by Auromedics: Recall - Presence of Glass Particles in Vial Administration of glass particulate may result in local irritation or swelling in response to the foreign material. More serious potential outcomes would include blockage and clotting in blood vessels, which may be life-threatening. Posted 01/04/2018 Compounded Sterile Products by PharMEDium Services: 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 01/02/2018 Reprocessed Agilis Steerable Introducer Sheath by Sterilmed: Class I Recall - Improper Seal of Sheath Hub Improper seals can allow blood to leak through the hub, cause the cap to fall off during the procedure, or can create a difference in pressure that allows air into the circulatory system (air embolism). Posted 01/02/2018