Search Results for: labeling

Thoratec Corporation Issues Worldwide Medical Device Correction of HeartMate II Left Ventricular Assist System (October 24)

October 27, 2008 By The FDA Leave a Comment

CONTACT: THORATEC CORPORATION 1-800-528-2577 FOR IMMEDIATE RELEASE -- PLEASANTON, CA -- OCTOBER 24, 2008&MDASH;THORATEC CORPORATION IS INITIATING A WORLDWIDE MEDICAL DEVICE CORRECTION OF ALL SERIAL NUMBERS OF THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEMS (HM II LVAS) HAVING CATALOGUE NO. 1355 OR 102139, WHICH HAVE BEEN DISTRIBUTED SINCE THE … [Read more...]

Russell Stover Candies Issues Hazelnut Allergy Alert for some Private Reserve Assorted Chocolates

October 11, 2008 By The FDA Leave a Comment

CONTACT: MR. ALLEN CAUDLE VOLLMER PUBLIC RELATIONS FOR RUSSELL STOVER CANDIES, INC. 713-970-2107 FOR IMMEDIATE RELEASE -- OCTOBER 9, 2008 -- KANSAS CITY, MO &NDASH; IN SPECIFIC U.S. MARKETS (BELOW), RUSSELL STOVER CANDIES, INC., IS RECALLING ONE LOT CODE OF ITS 2 7/8 OZ SIZE OF PRIVATE RESERVE ASSORTED CHOCOLATES BECAUSE ONE PIECE OF CANDY IN THE … [Read more...]

Just Say NO to Genetically Engineered Animals in Our Food Supply

September 30, 2008 By E. Sizemore 10 Comments

Although the US Food and Drug Administration has already stated that cloned animals are safe to eat, there are currently no genetically engineered animals approved as food for human consumption by the FDA. That may soon change. The FDA updated their fact sheet on genetically engineered animals last week and have opened up a forum for public … [Read more...]

CaJohns Fiery Foods Company Recalls HDH Grillin Sauce

September 26, 2008 By The FDA Leave a Comment

CONTACT: CAJOHNS FIERY FOODS 888-703-3473 FOR IMMEDIATE RELEASE -- SEPTEMBER 24, 2008 -- CAJOHNS FIERY FOODS COMPANY IS RECALLING A TOTAL OF 103 INDIVIDUAL BOTTLES OF HDH GRILLIN' SAUCE SOLD BETWEEN THE DATES OF 01/01/07 AND 09/15/08. THIS RECALL IS INITIATED DUE TO THE POSSIBILITY OF NON-DECLARED CONTENTS ON THE INGREDIENT DECLARATION. THE … [Read more...]

FDA Says Don't Feed Infant Forumula Made in China to Infants

September 13, 2008 By The FDA Leave a Comment

IN RESPONSE TO REPORTS OF CONTAMINATED MILK-BASED INFANT FORMULA MANUFACTURED IN CHINA, THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) TODAY IS ISSUING A HEALTH INFORMATION ADVISORY. THIS IS TO ASSURE THE AMERICAN PUBLIC THAT THERE IS NO KNOWN THREAT OF CONTAMINATION IN INFANT FORMULA MANUFACTURED BY COMPANIES THAT HAVE MET THE REQUIREMENTS TO SELL … [Read more...]