MedWatch Safety Alerts

Highly Concentrated Potassium Chloride Injection, 10 mEq per 100 mL by Baxter: Recall - Mislabeled Overpouch

Administration of a dose lower than intended, especially in patients prone to severe electrolyte imbalance, may lead to serious, life-threatening adverse health consequences.

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Forever Beautiful Bee Pollen by REFA Enterprises: Recall - Undeclared Drug Ingredients

Risk for those with a history of coronary artery disease, congestive heart failure, arrhymias or stroke

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Intravia Containers by Baxter: Recall - Particulate Matter

UPDATED 11/20/2014. Recall Classified as Class I. Particles may irritate patient’s veins, cause pain, worsen a previous infection, cause allergic reactions, block blood vessels, and cause death.

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Respironics California, Esprit V1000 and V200 Ventilators: Class I Recall - Power Failure May Occur

Failure of power supply may cause ventilator to shut off, resulting in too much carbon dioxide or not enough oxygen in patient’s blood, or death.

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ABC Dophilus Powder by Solgar, Inc: Recall - Risk of Infection

The product was found to contain Rhizopus oryzae, which may cause health problems to consumers, particularly premature infants/infants, children, and those with weakened immune systems.

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Long-term Antiplatelet Therapy: Safety Announcement - Preliminary Trial Data Shows Benefits But a Higher Risk of Non-Cardiovascular Death

FDA believes the benefits of clopidogrel (Plavix) and prasugrel (Effient) therapy continue to outweigh their potential risks when used for approved uses.

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Gel-E Donut and Squishon 2 Products by Children’s Medical Ventures: Recall - Potential Mold Contamination

There is the possibility of fungal infection should patients come in contact with the mold.

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