FDA NEWS

Myfortic (mycophenolate acid)
Dear Healthcare Professional Letter sent by manufacturer regarding reports of Progressive Multifocal Leukoencephalopathy in patients treated with Myfortic.

2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation Product
Product recalled due to the presence of Burkholderia cepacia.

April 2008 Monthly Safety Labeling
Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of the Prescribing Information, plus Patient Package Inserts and Medication Guides.

Bay Valley Foods Issues Allergy Alert on Undeclared Milk in Mislabeled Kroger Chicken Noodle Soup (June 24)
The recalled product, Kroger Chicken Noodle Soup, comes in 10.5 ounce cans and is marked with lot code 52104098, and a "best before" date code of 40910 (April 9, 2010) that can be found on the bottom of the can. Consumers are urged to return the product to the store where it was purchased for a full refund.

FDA 101: Advisory Committees
FDA's Advisory Committees are critical to the agency's product review process. Find out the basics of putting special government employees with different perspectives on such scientific committees.

FDA Requests Seizure of Animal Food Products at PETCO Distribution Center
At the request of the U.S. Food and Drug Administration (FDA), U.S. Marshals seized various animal food products stored under unsanitary conditions at the PETCO Animal Supplies Distribution Center located in Joliet, Ill., pursuant to a warrant issued by the United States District Court in Chicago.

Stronger Warnings Requested for Fluoroquinolones
FDA has notified manufacturers of fluoroquinolones that a boxed warning on the increased risk of tendinitis and tendon rupture is necessary.

Giant Food Alerts Customers to Voluntary Recall of Giant Brand Garlic Bread and Garlic Spread (June 27)
Giant Food has announced a voluntary recall of Giant brand garlic bread and garlic spread products sold in its Bakeshop as the items contain milk products which are not declared on the labels. Giant removed from its shelves all 16 ounce packages of Giant brand garlic bread and all 16 ounce packages of Giant brand garlic spread products.

Matterhorn Group Inc. Announces Voluntary Recall of Astro Pops and Missile Pops 3.5 oz Cherry Pineapple Frozen Novelty Pops in Arizona, Nevada and California due to Safety Hazard (June 18)
Matterhorn Group Inc is recalling certain date coded product of their Rainbow Glacier "Astro Pops" water ice frozen novelty pops, Cherry Pineapple Swirl 3.5 oz size 12 count bag pack, with tag closure "Best by JUN 03-09", "Best by JUN 04-09" and "Best by JUN 05-09" sold through the Wal-Mart stores located in California and Arizona, Sunnyside Farms "Missile Pops" Cherry Pineapple in 3.5 oz. size 12 count bag packages, with tag closure of "Best By JUN 02-09", "Best by JUN 03-09", and "Best by JUN 04-09" sold through the California stores of grocery retailers Save Mart and Raley’s, and Vitafreze Frozen Astronot Pops 3.5 oz size 12 count bag packages, with tag closure of "Best By JUN 02-09" sold in California. The products are being recalled because they may contain pieces of hard plastic. Only the noted product date codes listed are affected.