Wednesday, December 22, 2010

New Requirements for Indoor Tanning Facilities Designed to Help Reduce Hazards


For Immediate Release: Dec. 22, 2010Media Inquiries: Erica Jefferson, 301-796-4988, erica.jefferson@fda.hhs.govConsumer Inquiries: 888-INFO-FDA
FDA announces recall of Abbott glucose test stripsStrips sold in retail stores, online and used in health care facilities
The U.S. Food and Drug Administration today announced the agency is working with Abbott Diabetes Care to recall 359 different lots of glucose test strips marketed under the following brand names:
Precision Xceed Pro;
Precision Xtra;
Medisense Optium;
OptiumEZ; and
ReliOn UltimaThese strips are used with Abbott’s Precision Xtra, Precision Xceed Pro, MediSense Optium, Optium, Optium EZ and ReliOn Ultima blood glucose monitoring systems. As many as 359 million strips may be affected by the recall. The blood glucose monitoring systems are not affected by this recall.
The recall pertains to certain lots of these test strips distributed in the United States and Puerto Rico. Other Abbott Diabetes Care products are not affected by the recall.
The test strips being recalled may give falsely low blood glucose results. False results may lead patients to try to raise their blood glucose unnecessarily, or they may fail to treat elevated blood glucose because of a false, low reading. Both scenarios pose risks to a patient’s health.
The recall is related to the test strips’ inability to absorb enough blood for monitoring. Strips exposed to warm weather or prolonged storage may be more likely to provide a false result.
The test strips were manufactured between January and September 2010 and are sold both in retail and online settings directly to consumers, but are also used in health care facilities.

Pfizer Adds Another Lot to October Lipitor Recall

December 21, 2010 (New York, New York) — Pfizer announced the recall of another lot--approximately 19 000 bottles--of atorvastatin (Lipitor) 40-mg tablets from the US market due to reports of the same "uncharacteristic odor" that prompted the recall of 191 000 bottles of Lipitor earlier this year [1]. The recalled lot is 0836050.
The company says that a medical assessment concluded that the risk of health consequences from taking drugs from this lot are minimal, but it is advising patients who have tablets from the recalled lot to return them to their pharmacist in exchange for a new bottle. Pfizer does not anticipate a shortage resulting from the recall.
After the first recall, the company found the odor was most likely coming from very low levels of tribromoanisole in the pill bottles supplied by an outside vendor. Tribromoanisole comes from a wood preservative used in pallets to transport and ship a variety of products. Pfizer prohibits its suppliers from using tribromoanisole-treated pallets to ship its products.
This is the fourth recall of this product for "odor" reasons.