From the category archives:

MedWatch

0.9 Percent Sodium Chloride Injection, USP, 250 mL by Hospira : Recall – Particulate Matter

January 23, 2015

Injected particulate material may result in local inflammation, phlebitis, and/or low-level allergic response. This is a summary of an alert issued by MedWatch: The FDA Safety Information and Adverse Event Reporting Program. The link below will take you to the original notice. View Full Details Of The Original MedWatch Notice Here.

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Bone Graft Substitutes Containing Recombinant Proteins or Synthetic Peptides in Patients Under Age 18: FDA Safety Communication – Reports of Serious Injuries

January 21, 2015

Risk of excess bone growth, fluid accumulation, inhibited bone healing, and swelling. This is a summary of an alert issued by MedWatch: The FDA Safety Information and Adverse Event Reporting Program. The link below will take you to the original notice. View Full Details Of The Original MedWatch Notice Here.

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Simulated IV Solutions from Wallcur: CDER Statement- FDA’s Investigation into Patients being Injected

January 14, 2015

Adverse events include fever, chills, tremors and headache,and there is one death associated with the use of these products. This is a summary of an alert issued by MedWatch: The FDA Safety Information and Adverse Event Reporting Program. The link below will take you to the original notice. View Full Details Of The Original MedWatch [...]

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Prescription and Over-the-Counter (OTC) Pain Medicines: Drug Safety Communication – FDA Review of Possible Risks of Pain Medicine Use During Pregnancy

January 9, 2015

Pregnant women urged to discuss all medicines with their health care professionals before using them. This is a summary of an alert issued by MedWatch: The FDA Safety Information and Adverse Event Reporting Program. The link below will take you to the original notice. View Full Details Of The Original MedWatch Notice Here.

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Virazole (Ribavirin Powder For Solution) by Valeant Pharmaceutical North America, LLC: Recall- Due to Microbial Contamination

January 2, 2015

Inhalation of a non-sterile product with microbial contamination into the airways could increase the risk of respiratory infection. This is a summary of an alert issued by MedWatch: The FDA Safety Information and Adverse Event Reporting Program. The link below will take you to the original notice. View Full Details Of The Original MedWatch Notice [...]

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KimVent Microcuff Subglottic Suctioning Endotracheal Tubes by Halyard Health: Class I Recall – Component May Detach During Use

December 31, 2014

An air leak between cuff and tracheal wall may reduce the amount of air that reaches the lungs. Use of this recalled product could cause serious health risks, including delayed patient treatment, breathing difficulties, and death. This is a summary of an alert issued by MedWatch: The FDA Safety Information and Adverse Event Reporting Program. [...]

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Nellcor Puritan Bennett 980 Ventilator System by Covidien: Class I Recall – Component Failure May Cause Burning Odor

December 31, 2014

Problems in the manufacturing process may lead to unexpected need to stop the ventilator and transfer the patient to another ventilator. This is a summary of an alert issued by MedWatch: The FDA Safety Information and Adverse Event Reporting Program. The link below will take you to the original notice. View Full Details Of The [...]

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IV Solutions from Wallcur of San Diego: CDER Statement – FDA Warns Health Care Professionals Not to Inject Patients

December 30, 2014

There have been reports of serious adverse events associated with the use of certain of these products. This is a summary of an alert issued by MedWatch: The FDA Safety Information and Adverse Event Reporting Program. The link below will take you to the original notice. View Full Details Of The Original MedWatch Notice Here.

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Caramel Apples: Warning – Illnesses, Including Deaths, Linked to Listeria Monocytogenes Contamination

December 25, 2014

Listeriosis can be fatal, especially in certain high-risk groups, including the elderly, and people with weakened immune systems and certain chronic medical conditions (such as cancer). This is a summary of an alert issued by MedWatch: The FDA Safety Information and Adverse Event Reporting Program. The link below will take you to the original notice. [...]

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Mitoxantrone by Hospira: Recall – Confirmed Subpotency and Out-Of-Specification

December 23, 2014

Potential for decreased potency which can lead to decreased effectiveness, additional dosing, and the potential for cumulative impurity toxicity requiring medical intervention. This is a summary of an alert issued by MedWatch: The FDA Safety Information and Adverse Event Reporting Program. The link below will take you to the original notice. View Full Details Of [...]

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