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FDA MedWatch Safety Alerts



Last Build Date: Fri, 24 Mar 2017 13:20:00 -0400

 



HeartStart MRx Monitor/Defibrillator by Phillips Healthcare: Class I Recall - Electrical Issues

Fri, 24 Mar 2017 13:20:00 -0400

A delay in delivering therapy could result in serious patient injury such as permanent organ damage, brain injury, or death.



Breast Implants: Update - Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)

Tue, 21 Mar 2017 13:00:00 -0400

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.



Absorb GT1 Bioresorbable Vascular Scaffold (BVS) by Abbott Vascular: Letter to Health Care Providers - FDA Investigating Increased Rate of Major Adverse Cardiac Events

Sat, 18 Mar 2017 10:00:00 -0400

Increased rate of major adverse cardiac events observed in patients receiving the BVS, when compared to patients treated with metallic XIENCE drug-eluting stent.



Viberzi (eluxadoline): Drug Safety Communication - Increased Risk of Serious Pancreatitis In Patients Without A Gallbladder

Wed, 15 Mar 2017 12:02:00 -0400

Patients who do not have a gallbladder should not take Viberzi. Developing pancreatitis could result in hospitalization or death.



SynchroMed II and SynchroMed EL Implantable Drug Infusion Pumps by Medtronic: Class I Recall - Failure of Priming Bolus

Tue, 14 Mar 2017 13:20:00 -0400

Patients may receive a drug overdose or under dose which can lead to serious adverse health consequences such as respiratory depression, coma or death.



Lifepak 1000 Defibrillators by Physio-Control: Voluntary Field Action - Immediately Remove and Reinstall Battery

Thu, 09 Mar 2017 14:23:00 -0500

Device has shut down unexpectedly during patient treatment, which may expose patients to the risk of serious harm or death. Posted 01/14/2017



Herbal and Dietary Supplement Products by Regeneca Worldwide: Recall - Not Manufactured in Compliance with Current Good Manufacturing Practices

Thu, 09 Mar 2017 13:40:00 -0500

Nationwide recall of Regeneca's entire line of herbal and dietary supplement products.



SPS-1 Static Preservation Solution distributed by Organ Recovery Systems: Safety Communication - FDA Warns Of Potential Contamination

Thu, 09 Mar 2017 11:00:00 -0500

Laboratory results confirmed contamination with Pantoea and Enterococcus (intrinsically vancomycin-resistant) bacteria.



Balloon angioplasty devices to treat autonomic dysfunction: FDA Safety Communication - FDA concern over experimental procedures

Wed, 08 Mar 2017 13:30:00 -0500

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



Dietary Supplements for Male Sexual Enhancement by A and H Focal: Recall - Undeclared Drug Ingredient

Tue, 07 Mar 2017 20:00:00 -0500

PDE-5 Inhibitors may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels.



Edex (alprostadil for injection) 10 mcg 2 Pack by Endo Pharmaceuticals: Recall - Potential Lack of Sterility Assurance

Mon, 27 Feb 2017 13:00:00 -0500

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.



Avella Specialty Pharmacy Unexpired Sterile Injectable Products Labeled “Latex Free”: Recall - Products May Contain Synthetic or Natural Latex

Fri, 24 Feb 2017 20:00:00 -0500

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.



XtraHRD Natural Male Enhancement Capsules by Organic Herbal Supply, Inc.: Recall - Undeclared Drug Ingredient

Wed, 22 Feb 2017 08:00:00 -0500

Undeclared tadalafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels.



Comprehensive Reverse Shoulder by Zimmer Biomet: Class I Recall - High Fracture Rate

Thu, 16 Feb 2017 09:30:00 -0500

Fractures may result in revision surgeries which could cause serious adverse health consequences such as permanent loss of shoulder function, infection, or rarely, death.



HCG (Human Chorionic Gonadotropin) Freeze Dried Vials by Synergy Rx: Recall - Lack of Sterility Assurance

Wed, 15 Feb 2017 08:30:00 -0500

Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening.



Alaris Syringe Pump Module (Large Volume Pump), Model 8100 and AIL Sensor Kits by CareFusion: Class I Recall - Alarm Error

Thu, 09 Feb 2017 11:00:00 -0500

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.



Ibuprofen Lysine Injection, 20 mg /2 mL (10 mg/mL) by Exela Pharma Sciences: Recall - Particulate Matter

Thu, 09 Feb 2017 09:35:00 -0500

Particulate matter has the potential to block blood vessels, provoke an immune reaction, and/or lead to microinfarcts which could be life threatening.



Well Balance Xanthium & Siler Combo (Bi Yan Pian) Dietary Supplement by Kingsway Trading Inc.: Recall - Product Contains Banned Ephedra Alkaloids

Thu, 09 Feb 2017 07:45:00 -0500

Supplements containing ephedrine alkaloids pose a risk of serious adverse events, including heart attack, stroke, and death.



Chlorhexidine Gluconate: Drug Safety Communication - Rare But Serious Allergic Reactions

Thu, 02 Feb 2017 13:24:00 -0500

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.



Halo One Thin-Walled Guiding Sheath by Bard Peripheral Vascular Inc.: Class I Recall - Sheath Separation, Kinking, or Tip Damage

Mon, 30 Jan 2017 14:10:00 -0500

The affected product may cause serious adverse health consequences such as internal tears and perforation to arteries or veins, excessive bleeding, and death.