May 19, 2009
 

Recalls and Safety Alerts: Welch Allyn Automated External Defibrillators (AED) Recalled


Recalls and Safety Alerts: Welch Allyn Automated External Defibrillators (AED) Recalled
The device company Welch Allyn is recalling about 14,000 automated external defibrillators. The affected models are AED 10 and MRL JumpStart defibrillators manufactured between October 3, 2002 and January 25, 2007. A number of problems have been...
Source: www.accessdata.fda.gov

May 2009 Patient Safety News
Video news show for healthcare professionals, covering safety alerts, recalls, product approvals, and important tips on protecting patients.
Source: www.fda.gov

FDA: More than $1.5 Million of Adulterated Food, Food Ingredients Seized
At the request of the U.S. Food and Drug Administration, U.S. Marshals today seized more than $1.5 million worth of food products, including herbs and botanicals, stored under filthy conditions at the American Mercantile Corporation of Memphis, Tenn.
Source: www.fda.gov

Recalls and Safety Alerts: Warning on Metoclopramide
FDA is requiring that manufacturers of metoclopramide add a boxed warning to the label about the risk of tardive dyskinesia if the drug is used for long periods of time or at high doses. Metoclopramide stimulates motility in the upper GI tract and i...
Source: www.accessdata.fda.gov

Tarceva (erlotinib)
Dear Healthcare Professional letter issued to warn about GI perforation, exfoliative skin conditions and corneal perforation/ulceration.
Source: www.fda.gov

April 2009 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.
Source: www.fda.gov

Hydroxycut Products
Dietary supplements are associated with serious liver injury, including liver failure, seizures, cardiovascular disorders, and rhabdomyolysis.
Source: www.fda.gov

Digoxin, USP 0.25 mg
UPDATE - Recall due to variance in amount of active ingredient.
Source: www.fda.gov

Biosite brand Triage Cardiac Panel
Use of affected lots of the Triage Cardiac Panel may lead to false negative results, possibly resulting in missed or incorrect diagnosis.
Source: www.fda.gov

Subscribe to Posts [Atom]