Food and Drug Adminstration (FDA): MedWatch

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

11/17/2008 01:30 PM
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)

11/12/2008 01:30 PM
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)

11/12/2008 01:30 PM
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)

11/10/2008 09:40 AM
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)

11/06/2008 08:15 AM
Recall due to mislabeling that could lead to incorrect insulin dosing.

September 2008 Safety-Related Labeling Changes

11/04/2008 08:50 AM
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

10/31/2008 04:30 PM
Class I recall because of unsupported claims.

November 2008 Patient Safety News

10/31/2008 02:00 PM
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

10/28/2008 02:15 PM
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.

Transvaginal Placement of Surgical Mesh

10/21/2008 02:40 PM
Serious complications associated with transvaginal placement of surgical mesh in repair of pelvic organ prolapse and stress urinary incontinence.

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