From the category archives:

MedWatch

Methotrexate Sodium, USP Injectable Vials by Sandoz US: Recall – Particulate Matter In Vials

May 21, 2013

Particulate matter in parenteral drugs has been recognized as a potential health hazard. 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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Abbott Diabetes Care: Class 1 Recall – FreeStyle InsuLinx Blood Glucose Meters – Risk of Incorrect Test Result

May 20, 2013

Incorrect test results at extremely high blood glucose levels. 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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All Sterile Drug Products Made and Distributed By NuVision Pharmacy Dallas Facility: Recall – Lack Of Sterility Assurance

May 18, 2013

If a drug product marketed as sterile has microbial contamination, patient is at risk of serious 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 Here.

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Compounded Prescription Therapies By Pentec Health Inc.: Recall – Lack Of Sterility Assurance

May 17, 2013

Patients are at increased risk of infection in the event a sterile product is compromised. 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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Atriphen dietary supplement (Xymogen brand): Recall – Potential Allergic Reaction Due to Milk and Soy

May 9, 2013

Risk of serious or life-threatening allergic reaction. 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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The Compounding Shop: FDA News Release – Lack of Sterility Assurance of Drug Products

May 8, 2013

These products should not be administered to patients. If a drug product marketed as sterile has microbial contamination, it potentially places patients at risk of serious 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 [...]

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SexVoltz, Velextra, and Amerect by Beomonstar Products: Recall – Undeclared Drug Ingredient

May 8, 2013

Undeclared tadalafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. 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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Lightning Rod Capsules: Recall – Undeclared Drug Ingredient

May 7, 2013

Testing revealed the product contains an analogue of sildenafil, which may interact with nitrates found in prescription drugs such as nitroglycerin, and lower blood pressure to dangerous levels. 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 [...]

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Bullet Proof: Public Notification – Undeclared Drug Ingredient

May 7, 2013

Testing revealed the product contains tadalafil, which may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels. 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 [...]

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Maquet SERVO-i Ventilator Battery Module: Class 1 Recall – Battery Run Time Shorter Than Expected

May 7, 2013

May result in unexpected ventilator shut downs, which can result in serious adverse health consequences, including death. 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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