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FDA MedWatch
FDA MedWatch Safety Alerts
Animas Corporation Battery Caps Used with the OneTouch Ping System, Animas 2020 Insulin Pump, Animas IR1200 Insulin Pump, and Animas IR1250 Insulin Pump
Potential for device to stop administering insulin, resulting in hyperglycemia or hypoglycemia.
Benzoyl Peroxide Acne Cream 10% marked as: DG Maximum Strength Acne Medicated Gel; Kroger Acne Gel 10% Benzoyl Peroxide Acne Medication; Equate: Medicated Acne Gel
Voluntary recall due to samples of the products containing Burkholderia Cepacia bacteria.
Update on Early Communication: Bisphosphonates marketed as Alendronate (Fosamax, Fosamax Plus D); Etidronate (Didronel); Ibandronate (Boniva); Pamidronate (Aredia); Risedronate (Actonel, Actonel W/Calcium); Tiludronate (Skelid); Zoledronic acid (Reclast, Zometa)
Early Communication about the FDA's review of safety data showed no clear association between overall bisphosphonate exposure and the rate of serious or non-serious atrial fibrillation
Infants' Mylicon Gas Relief Dye Free Drops (Simethicone-Antigas)
Product recalled because some bottles of the product could include metal fragments..
Propafenone HCl Tablets (150 mg, 225 mg, 300 mg), Isosorbide Mononitrate Extended Release Tablets (30 mg and 60 mg), Morphine Sulfate Extended Release Tablets (15 mg), Morphine Sulfate Immediate Release Tablets (15 mg and 30 mg), Dextroamphetamine Sulfate Tablets (10 mg)
Generic products recalled because of the potential for oversized tablets that could cause serious or life-threatening consequences.
ReliOn Insulin Syringes for use with U-100 Insulin (Tyco Healthcare - Covidien)
Recall due to mislabeling that could lead to incorrect insulin dosing.
September 2008 Safety-Related Labeling Changes
Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of drug Prescribing Information, plus Patient Package Inserts and Medication Guides.
Vibe Technologies Vibrational Integrated Bio-photonic Energizer Machine Multi-Frequency Field Generator
Class I recall because of unsupported claims.
November 2008 Patient Safety News
Patient Safety News is a video news show for healthcare professionals, covering safety alerts, recalls, product approvals, and important tips on protecting patients.
Thoratec HeartMate II Left Ventricular Assist System
Device correction because the wear and fatigue of the percutaneous lead connecting the blood pump with the system controller may cause serious injury or death.