Posts Tagged ‘Recall’

Nearly a million doses of H1N1 vaccine for infants and toddlers (ages 6 months – 3 years) were recalled on Tuesday. The vaccine reportedly lost strength since its distribution throughout the country last month. The vaccine was strong when the shots were originally shipped, according to the manufacturer, Sanofi Pasteur; however, tests done weeks later revealed the potency had fallen about 12 percent below the government standard.

By now, most of the shipment has already been used, but doctors are asked to return any unused doses.

Officials with the U.S. Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC) and Sanofi Pasteur say the strength of the vaccine is still high enough to protect children who received it. Parents can rest assured that already injected vaccine dosages are safe and effective, according to Dr. Anne Schuchat, a  CDC flu expert.

The U.S. Food and Drug Administration (FDA) and Edwards Lifesciences notified health care professionals, Nov. 9, about the Class 1 recall of CardioVations EndoClamp™ Aortic Catheter, model numbers EC1001 and EC65. The recall was initiated because the balloon catheters may spontaneously rupture during surgery.

This product was manufactured from August 2008 through August 2009 and distributed from November 2008 through September 2009.

The device blocks off the aorta, monitors aortic pressure, and delivers solution to stop the heart during cardiopulmonary bypass procedures.

On Oct. 29, 2009, the manufacturer sent a follow-up letter to their customers instructing them to:

• Check their inventory and identify any unused product; and 
• Return unused products to the company.

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of this product to the FDA’s MedWatch Adverse Event Reporting program.

The U.S. Food and Drug Administration (FDA) seized 11 lots of contaminated heparin—a blood thinner drug—from Celsus Laboratories Inc. on Nov. 6, according to an FDA news release.

The 11 lots consisted of five lots of Heparin Sodium Active Pharmaceutical Ingredient (API) and six lots of Heparin Lithium. These products were manufactured in China and found to be contaminated with over-sulfated chondroitin sulfate (OSCS)—a substance that mimics heparin’s anticoagulant activity. Read more »

Let diabetic patients know Tyco Healthcare Group LP (Covidien) recalled one lot of ReliOn 31-gauge, 1cc insulin syringes due to possible mislabeling.

According to a U.S. Food and Drug Administration Nov. 5 news release, there was a mix up during the packaging process and some syringes labeled for use with U-40 insulin were mixed with syringes labeled for use with U-100 insulin. The syringes were then packaged individually and boxed as 100 units for use with U-100 insulin. Read more »