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FDA MedWatch Newsfeed FDA MedWatch Safety Alert
FDA MedWatch Newsfeed FDA MedWatch Safety Alert
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All Sterile Drug Products Made and Distributed By NuVision Pharmacy Dallas Facility: Recall - Lack Of Sterility Assurance
If a drug product marketed as sterile has microbial contamination, patient is at risk of serious infection.
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Compounded Prescription Therapies By Pentec Health Inc.: Recall - Lack Of Sterility Assurance
Patients are at increased risk of infection in the event a sterile product is compromised.
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Zolpidem Containing Products: Drug Safety Communication - FDA Requires Lower Recommended Doses
UPDATED 05/14/2013. FDA has approved label changes specifying new dosing recommendations for zolpidem products.
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Atriphen dietary supplement (Xymogen brand): Recall - Potential Allergic Reaction Due to Milk and Soy
Risk of serious or life-threatening allergic reaction.
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The Compounding Shop: FDA News Release - Lack of Sterility Assurance of Drug Products
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.
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SexVoltz, Velextra, and Amerect by Beomonstar Products: Recall - Undeclared Drug Ingredient
Undeclared tadalafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels.
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Bullet Proof: Public Notification - Undeclared Drug Ingredient
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.
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Lightning Rod Capsules: Recall - Undeclared Drug Ingredient
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.
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Maquet SERVO-i Ventilator Battery Module: Class 1 Recall - Battery Run Time Shorter Than Expected
May result in unexpected ventilator shut downs, which can result in serious adverse health consequences, including death.
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Medtronic: Class 1 Recall - Medtronic Deep Brain Stimulation Lead Kit and Activa Dystonia HDE Kit
Use of lead cap may cause lead damage. Lead replacement may be required or optimal therapy may not be provided.
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Covidien Surgical Stapler Reloads: FDA Safety Communication - Devices Stolen Before They Were Sterilized
Use of these non-sterile products could increase the risk of infection in surgical patients.
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Cardinal Health: Class 1 Recall - Various Presource Kits Containing a Pre-Assembled Anesthesia Circuit
Plastic packaging may become lodged in the filter potentially causing an obstruction in airflow, which may result in low blood oxygen (hypoxia), suffocation and death.
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Valproate Anti-Seizure Products: Drug Safety Communication - Contraindicated for Pregnant Women for Prevention of Migraine Headaches
Based on a recent study, there is evidence that these medications can cause decreased IQ scores in children whose mothers took them while pregnant.
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Kadcyla (ado-trastuzumab emtansine): Drug Safety Communication - Potential Medication Errors Resulting from Name Confusion
Use of the incorrect nonproprietary name for Kadcyla in some medication-related electronic systems poses a risk of mix-up with Herceptin (trastuzumab).
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American Lifestyle Vicerex and Black Ant Capsules: Recall - Undeclared Drug Ingredient
Laboratory analysis has found tadalafil and sildenafil.
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Hospira Inc., GemStar Infusion System: Recall - Lithium Battery Low Voltage
UPDATED 05/01/2013. Damage from battery leakage may cause the device to shut off without warning.
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Newport Medical Instruments, Inc., HT70 and HT70 Plus Ventilators: Class I Recall - Unit Goes Into Internal Backup Battery Sooner Than Expected
The screen on the ventilator may indicate that the Power Pac battery is fully charged when it is not, or the unit may switch to backup battery power as soon as it is removed from AC power.
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Anticoagulant Citrate Phosphate Dextrose Solution, USP (CPD) BLOOD-PACK Unit By Fenwal: Recall - Labeling Issue Identified
The platelet container is incorrectly labeled as “AS-1 Red Blood Cell Adenine-Saline added”.
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Samsca (Tolvaptan): Drug Safety Communication - FDA Limits Duration and Usage Due To Possible Liver Injury Leading to Organ Transplant or Death
An increased risk of liver injury was observed in recent large clinical trials evaluating Samsca.
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Piperacillin and Tazobactam for Injection, USP 40.5 grams: Recall - Precipitation or Crystallization in IV Bag or IV Line Upon Reconstitution
Administration of precipitated Piperacillin/Tazobactam can lead to serious adverse events.
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