List of FDA Medical Watch Alerts
| Date Reported | Drug Name | Status |
|---|---|---|
| 07/09/2015 | Non-aspirin Nonsteroidal Anti-inflammatory Drugs (NSAIDs): Drug Safety Communication - FDA Strengthens Warning of Increased Chance of Heart Attack or Stroke | Patients and health care professionals should remain alert for heart-related side effects the entire time that NSAIDs are being taken. |
| 07/02/2015 | Lifesaver Single Patient Use Manual Resuscitator by Teleflex Hudson RCI: Class I Recall - Intake Port Blockage | Recalled device may not deliver breathing support to the patient. A delay in treatment may potentially lead to patient injury or death. |
| 07/01/2015 | Unapproved Prescription Ear Drop (Otic) Products: Not FDA Evaluated for Safety, Effectiveness and Quality | Unapproved products may be contaminated or manufactured incorrectly, which could result in patients receiving the wrong dose, even when administered according to the labeled directions for use. |
| 07/01/2015 | Codeine Cough-and-Cold Medicines in Children: Drug Safety Communication - FDA Evaluating Potential Risk of Serious Side Effects | FDA investigating the safety of codeine-containing medicines to treat coughs and colds in children under 18 years because of the potential for slowed or difficult breathing. |
| 07/01/2015 | FLOW-i Anesthesia Systems by Maquet: Class I Recall - Dislodged Patient Cassette May Stop Patient Ventilation | May cause anesthesia gas to leak and could prevent the ventilator from providing breathing support if not corrected immediately. |
| 06/24/2015 | Daytrana Patch (methylphenidate transdermal system): Drug Safety Communication - Permanent Skin Color Changes | New warning added to drug label to describe risk of chemical leukoderma. chemical leukoderma, have been associated with the use of the Daytrana patch. |
| 06/24/2015 | Covidien Shiley Neonatal and Pediatric Tracheostomy Tubes by Medtronic: Recall - Tubes Formed With Wider-angle Bend Than Standard Models | Reports of 12 serious patient injuries, including breathing difficulties that impacted oxygen levels in patients. |
| 06/24/2015 | Daytrana Patch (methylphenidate transdermal system): Drug Safety Communication - Permanent Skin Color Changes | New warning added to drug label to describe risk of chemical leukoderma. chemical leukoderma, have been associated with the use of the Daytrana patch. |
| 06/24/2015 | Covidien Shiley Neonatal and Pediatric Tracheostomy Tubes by Medtronic: Recall - Tubes Formed With Wider-angle Bend Than Standard Models | Reports of 12 serious patient injuries, including breathing difficulties that impacted oxygen levels in patients. |
| 06/22/2015 | HeartWare Ventricular Assist System: Class I Recall – Updated with Multiple Reasons for Recall | FDA will update recall with new information as it becomes available. |
| 06/22/2015 | HeartWare Ventricular Assist System: Class I Recall – Updated with Multiple Reasons for Recall | FDA will update recall with new information as it becomes available. |
| 06/19/2015 | M/L Taper with Kinectiv Technology Prosthesis by Zimmer: Class I Recall - Higher than Expected Levels of Manufacturing Residues | Can cause serious adverse health issues including allergic reactions, pain, infections, or death. |
| 06/19/2015 | M/L Taper with Kinectiv Technology Prosthesis by Zimmer: Class I Recall - Higher than Expected Levels of Manufacturing Residues | Can cause serious adverse health issues including allergic reactions, pain, infections, or death. |
| 06/16/2015 | HeartWare Ventricular Assist System: Class I Recall - Damaged Alignment Guides or Connection Pins May Cause Pump to Stop | An interruption in electrical connection would cause the pump to stop, which could cause serious patient injury or death. |
| 06/16/2015 | Potiga (ezogabine): Drug Safety Communication - FDA Determines 2013 Labeling Adequate to Manage Risks of Retinal Abnormalities, Potential Vision Loss, and Skin Discoloration | Health care professionals should continue to follow the recommendations provided in the BOXED WARNING, FDA’s most serious type of warning, and the WARNINGS AND PRECAUTIONS and INDICATIONS AND USAGE sections of the labeling. |
| 06/16/2015 | HeartWare Ventricular Assist System: Class I Recall - Damaged Alignment Guides or Connection Pins May Cause Pump to Stop | An interruption in electrical connection would cause the pump to stop, which could cause serious patient injury or death. |
| 06/16/2015 | Potiga (ezogabine): Drug Safety Communication - FDA Determines 2013 Labeling Adequate to Manage Risks of Retinal Abnormalities, Potential Vision Loss, and Skin Discoloration | Health care professionals should continue to follow the recommendations provided in the BOXED WARNING, FDA’s most serious type of warning, and the WARNINGS AND PRECAUTIONS and INDICATIONS AND USAGE sections of the labeling. |
| 06/08/2015 | Injectable Products by Mylan: Recall - Presence of Particulate Matter | UPDATED 06/08/2015. Recall Expanded. Administration of a sterile injectable that has foreign particulates has the potential of severe health consequences. |
| 06/08/2015 | Injectable Products by Mylan: Recall - Presence of Particulate Matter | UPDATED 06/08/2015. Recall Expanded. Administration of a sterile injectable that has foreign particulates has the potential of severe health consequences. |
| 06/03/2015 | Vascu-Guard Peripheral Vascular Patch by Baxter: Recall - Difficulty Distinguishing the Smooth from Rough Surface | Incorrect orientation of the patch with the rough side toward the bloodstream may increase the risk of vessel thrombosis and/or embolism. Posted 06/03/2015 |
| 06/03/2015 | Vascu-Guard Peripheral Vascular Patch by Baxter: Recall - Difficulty Distinguishing the Smooth from Rough Surface | Incorrect orientation of the patch with the rough side toward the bloodstream may increase the risk of vessel thrombosis and/or embolism. Posted 06/03/2015 |
| 05/28/2015 | Unintentional Injection of Soft Tissue Filler into Blood Vessels in the Face: FDA Safety Communication - Risk of Serious Patient Injury | Risk of embolization, which can cause vision impairment, blindness, stroke and damage and/or death of the skin and underlying facial structures. |
| 05/28/2015 | Unintentional Injection of Soft Tissue Filler into Blood Vessels in the Face: FDA Safety Communication - Risk of Serious Patient Injury | Risk of embolization, which can cause vision impairment, blindness, stroke and damage and/or death of the skin and underlying facial structures. |
| 05/27/2015 | Avea Ventilator by CareFusion: Recall - Potential Malfunction of Pressure Transducer | Ventilator may activate false Extended High Ppeak or Circuit Occlusion audio and visual alarms, open the safety valve and stop ventilating. |
| 05/27/2015 | Avea Ventilator by CareFusion: Recall - Potential Malfunction of Pressure Transducer | Ventilator may activate false Extended High Ppeak or Circuit Occlusion audio and visual alarms, open the safety valve and stop ventilating. |
| 05/20/2015 | Zerbaxa (ceftolozane and tazobactam): Drug Safety Communication - FDA Cautions About Dose Confusion and Medication Errors | Can lead to administration of more drug than was prescribed. |
| 05/20/2015 | Zerbaxa (ceftolozane and tazobactam): Drug Safety Communication - FDA Cautions About Dose Confusion and Medication Errors | Can lead to administration of more drug than was prescribed. |
| 05/15/2015 | SGLT2 inhibitors: Drug Safety Communication - FDA Warns Medicines May Result in a Serious Condition of Too Much Acid in the Blood | High levels of blood acids called ketones may require hospitalization. Posted 05/15/2015 |
| 05/15/2015 | Testosterone Products: Drug Safety Communication - FDA Cautions About Using Testosterone Products for Low Testosterone Due to Aging; Requires Labeling Change to Inform of Possible Increased Risk of He | UPDATED 05/15/2015. Testosterone product labels updated. |
| 05/15/2015 | SGLT2 inhibitors: Drug Safety Communication - FDA Warns Medicines May Result in a Serious Condition of Too Much Acid in the Blood | High levels of blood acids called ketones may require hospitalization. Posted 05/15/2015 |
| 05/15/2015 | Testosterone Products: Drug Safety Communication - FDA Cautions About Using Testosterone Products for Low Testosterone Due to Aging; Requires Labeling Change to Inform of Possible Increased Risk of He | UPDATED 05/15/2015. Testosterone product labels updated. |
| 05/13/2015 | LifeCare PCA3 and PCA5 Infusion Pump Systems by Hospira: FDA Safety Communication - Security Vulnerabilities | An unauthorized user with malicious intent could access the pump remotely and modify the dosage it delivers, which could lead to over- or under-infusion of critical therapies. |
| 05/13/2015 | LifeCare PCA3 and PCA5 Infusion Pump Systems by Hospira: FDA Safety Communication - Security Vulnerabilities | An unauthorized user with malicious intent could access the pump remotely and modify the dosage it delivers, which could lead to over- or under-infusion of critical therapies. |
| 05/07/2015 | Tiger Paw System II by Maquet Medical Systems: Class I Recall - May Cause Tears and Bleeding in Heart Tissue | Possibility of a tear on the left atrial wall during use of the device. |
| 05/07/2015 | Tiger Paw System II by Maquet Medical Systems: Class I Recall - May Cause Tears and Bleeding in Heart Tissue | Possibility of a tear on the left atrial wall during use of the device. |
| 05/05/2015 | Adrucil (fluorouracil Injection, USP) 5 g/100 mL (50 mg/mL): Recall - Particulate Matter | Administration of product with particulate matter has potential to result in inflammation, allergic reactions, or blockage of blood vessels, which may be life-threatening if vital organs are affected. |
| 05/05/2015 | Adrucil (fluorouracil Injection, USP) 5 g/100 mL (50 mg/mL): Recall - Particulate Matter | Administration of product with particulate matter has potential to result in inflammation, allergic reactions, or blockage of blood vessels, which may be life-threatening if vital organs are affected. |
| 04/30/2015 | Mammograms at Coastal Diagnostic Center in Pismo Beach, California: FDA Safety Communication - Quality Problems | Patients may need a repeat mammogram or additional medical follow-up. |
| 04/30/2015 | Mammograms at Coastal Diagnostic Center in Pismo Beach, California: FDA Safety Communication - Quality Problems | Patients may need a repeat mammogram or additional medical follow-up. |
| 04/24/2015 | Bupivacaine HCl Injection by Hospira: Recall - Iron Oxide Particulate In Glass Vials | Injected particulate may result in local inflammation, low-level allergic or immune responses, granuloma formation or mechanical irritation of tissue. |
| 04/23/2015 | Ebola Virus One-Step Test Kits by LuSys Laboratories: Class I Recall - Not Cleared for Marketing | The results obtained from these test kits have not been demonstrated to be accurate and should not be used as diagnostic tests for Ebola infection. Posted 04/23/2015 |
| 04/22/2015 | Mucinex Fast-MAX Products: Recall - Incorrect Labeling | Consumers could take a product with undeclared levels of acetaminophen, dextromethorphan, guaifenesin, phenylephrine and/or diphenhydramine. |