FDA News Digest
April 7, 2008
IN THIS WEEK’S ISSUE
— FDA Approves New Vaccine to Prevent Gastroenteritis Caused by Rotavirus
— Federal Agents Seize More Than $1.3 Million of Illegal Dietary Supplements
» Safety Alerts/Recalls
n Harry and David Chocolate Covered Select Blend Espresso Beans
n HC Fresh Frozen Salted Croaker
n Malt-O-Meal brand and other private labels
FDA Approves New Vaccine to Prevent Gastroenteritis Caused by Rotavirus
FDA has approved Rotarix, the second oral U.S. licensed vaccine for the prevention of rotavirus, an infection that causes gastroenteritis (vomiting and diarrhea) in infants and children. Rotarix is a liquid given in a two-dose series to infants from 6 to 24 weeks of age. Rotavirus causes about 2.7 million cases of gastroenteritis in U.S. children each year. About 55,000 to 70,000 of those require hospitalization, and between 20 and 60 deaths are attributed to it.
Illegal Dietary Supplements Marketed for use by Body Builders.
Federal Agents Seize More Than $1.3 Million
At FDA‘s request, U.S. marshals have seized more than $1.3 million of dietary supplements from Michigan-based LG Sciences, LLC. These products — marketed and distributed online and in retail stores under the names “Methyl 1-D,” “Methyl 1-D XL,” and “Formadrol Extreme XL” –contain unapproved food additives or ingredients that cause the products to violate the law. Labeled as dietary supplements, the products are marketed for use by body builders.
› Harry and David Chocolate Covered Select Blend Espresso Beans, 8-oz. size
Reason for recall: milk component not declared on package
› HC Fresh Frozen Salted Croaker (distributed in New York , New Jersey , Pennsylvania , Illinois and Texas)
Reason for recall: possible Clostridium botulinum contamination
› Unsweetened Puffed Rice and unsweetened Puffed Wheat, marketed under the Malt-O-Meal brand and other private labels, with “Best If Used By” dates between April 8, 2008 (coded as “APR0808”), and March 18, 2009 (coded as “MAR1809”)
Reason for recall: possible Salmonella contamination
For a list of recalls, market withdrawals, and safety alerts involving FDA-regulated
products from the past 60 days, go to http://www.fda.gov/opacom/7alerts.html.