FDA MedWatch

Cardiac Science Corp. Powerheart and CardioVive Automated External Defibrillators: Initial Communication

Defective components may cause affected devices to not deliver electric shocks, and the device's self-test may not detect the defect in advance of use.

Vicks Sinex Nasal Spray - Recall

Product found containing the bacteria B. cepacia.

RockHard Weekend - product contains undeclared drug ingredient

Recall of product, sold as a dietary supplement, containing undeclared sulfoaildenafil.

Cardiovascular Systems ViperSheath Sheath Introducer - Recall

Nationwide recall due to stretching or fracture of the sheath during use.

IDS Sports Dietary Supplements - Recall

Five products marketed as dietary supplements contain undeclared substances considered to be steroids.

Clopidogrel (marketed as Plavix) and Omeprazole (marketed as Prilosec) - Drug Interaction

Effectiveness of clopidogrel is reduced when taken with omeprazole, placing patients who use clopidogrel to prevent blood clots at risk for heart attacks or strokes if they are also taking omeprazole.

Negative Pressure Wound Therapy (NPWT) systems - Public Health Notification

Reports of deaths and serious complications, especially bleeding and infection, associated with NPWT.

Pai You Guo, Marketed as Dietary Supplement - Recall

Weight loss product contains undeclared drug ingredients sibutramine and phenolphthalein.

Local Anesthetics, Continuously Infused (marketed as bupivacaine, chlorprocaine, lidocaine, mepivacaine, procaine, ropivacaine) - Chondrolysis

Reports of chondrolysis in patients given continuous intra-articular infusions of local anesthetics with elastomeric infusion devices.

Genzyme Products, Marketed as Cerezyme, Fabrayzme, Myozyme, Aldurazyme, and Thyrogen

Foreign particle contamination of several products manufactured by Genzyme, which may lead to serious adverse events including damage to blood vessels or embolic events, and anaphylactic, allergic and immune-mediated reactions.

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