FDA NEWS

ETHEX Corporation Voluntarily Recalls Three Lots of Dextroamphetamine Sulfate 5mg Tablets Due to the Potential for Oversized Tablets (October 15)
ETHEX Corporation announced today that it has voluntarily recalled three specific lots (77946, 81141 and 81142) of Dextroamphetamine Sulfate 5 mg tablets, as a precaution, due to the possible presence of oversized tablets. Oversized tablets may contain as much as about twice the labeled amount of the active ingredient. The recalled lots were distributed by ETHEX Corporation under an "ETHEX" label between January 2007 and May 2008. The 5 mg product is an orange round tablet debossed with "ETHEX" and "311" on one side.

Outsmarting Poison Ivy and Other Poisonous Plants
Poison ivy and other poisonous plants are a hazard all year round. Here are tips for preventing and treating the itchy rash and blisters.

Use Caution With Ayurvedic Products
The presence of heavy metals in some Ayurvedic products makes them potentially harmful.

Russell Stover Candies, Inc. Issues Hazelnut Allergy Alert for the 2 7/8 Oz Size Of Private Reserve Assorted Chocolates (October 9)
The recalled product was distributed in the following states and cities: Texas, California, Louisiana, North Carolina, South Carolina, Virginia, Tennessee; Southaven, Mississippi; Billings, Montana; Sparks, Nevada; and Madison Heights, Michigan. An investigation determined 29 boxes of this candy may have been purchased by consumers, and up to another 188 boxes may have reached retail store locations. All the retail stores have been contacted to have the suspected product removed from the shelves.

Arnold Foods Company, Inc. Issues Allergy Alert on Undeclared Nuts in Brownberry Whole Grains Bread 100 Percent Whole Wheat (October 8)
The product being recalled has a green twist tie with a code date of "Oct 11" printed on the bread bag. No other Arnold brand or Brownberry brand products are affected.

Consumer Alert: Possible Botulism Contamination in Frozen Salted Croaker (October 6)
New York State Agriculture Commissioner alerted consumers not to eat Frozen Salted Croaker distributed by YS Trading Corp, Long Island City, New York because the product was uneviscerated. The Frozen Salted Croaker was sold in Hicksville, New York, Flushing, New York, and New Jersey in un-coded, unlabeled plastic bags.

Is It Really FDA Approved?
Some marketers say their products are "FDA approved", but how can you know for sure?

HHS/FDA Grants Tentative Approval for 75th Generic Anti-Retroviral Drug as Part of President's Emergency Plan for AIDS Relief
Marketed by Macleods Pharmaceuticals, Ltd, of Kachigam, Daman, in the Republic of India, the 75th drug is 150 milligram and 300 milligram tablets of generic lamivudine, a nucleoside analog reverse-transcriptase inhibitor (nRTI), which blocks an enzyme called reverse transcriptase, important to HIV production. HIV-infected patients who take lamivudine with other anti-HIV treatments develop less opportunistic infections.

Thoratec Corporation Issues Worldwide Medical Device Correction of HeartMate II Left Ventricular Assist System (October 24)
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 beginning of clinical studies in November 2003. Over time, wear and fatigue of the percutaneous lead connecting the HeartMate II LVAS blood pump with the System Controller may result in damage that could interrupt pump function, require reoperation to replace the pump and potentially result in serious injury or death.