Subject: Grand Supercenter, Inc. Recalls Frozen Salted Croaker Because of Possible Health Risk (April 1)
Grand Supercenter, Inc. Recalls Frozen Salted Croaker Because of Possible Health Risk (April 1)
Thu, 3 Apr 2008 07:47:00 -0500
Grand Supercenter, Inc. of Lyndhurst, NJ is recalling the following product because they have the potential to be contaminated with Clostridium botulinum, a bacterium, which can cause life-threatening illness or death.
Update : 2
Subject: Interstate Milk Shippers Update April 2008
***Interstate Milk Shippers List ***
The April 2008 Interstate Milk Shippers List is now available at http://www.cfsan.fda.gov/~ear/ims-toc.html.
Update : 3
Subject: FDA Approves New Vaccine to Prevent Gastroenteritis Caused by Rotavirus
FDA Approves New Vaccine to Prevent Gastroenteritis Caused by Rotavirus
Thu, 3 Apr 2008 18:00:00 -0500
The U.S. Food and Drug Administration today announced the approval of 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 and given in a two-dose series to infants from 6 to 24 weeks of age.
Update : 4
Subject: Taylor Fresh Foods Issues Voluntary Recall on Cut Fruit Product with Honduran Cantaloupes Due to Potential Health Risk (April 3)
Taylor Fresh Foods Issues Voluntary Recall on Cut Fruit Product with Honduran Cantaloupes Due to Potential Health Risk (April 3)
Thu, 3 Apr 2008 18:26:00 -0500
The products being recalled include cut cantaloupe and mix cut fruit in bowls and trays of all sizes distributed by Taylor Fresh Foods. Retail and convenience store products involved were removed from sale prior to Monday, March 24. Foodservice distributors, who sell their own brand, have been notified. Labels include the following: Taylor Farms Gourmet Fruit Tray featuring Creamy Yogurt Dip, Taylor Fresh Melon Mix, Taylor Fresh Fruit Mix, Fresh Fruit Tray with Creamy Strawberry Dip, with Best if Used By Dates before March 30, 2008. Any dates after this are not affected.
Update : 5
Subject: CDER New 4/3/2008
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April 3, 2008
- New and Generic Drug Approvals
- Dibenzyline (phenoxybenzamine hydrochloride) Capsules, WellSpring Pharmaceutical, Labeling Revision
- Phenergan Fortis (promethazine hydrochloride) Syrup, ANI Pharma, Manufacturing Change or Addition
- Phenergan Plain (promethazine hydrochloride) Syrup, ANI Pharma, Manufacturing Change or Addition
- Phenergan with Dextromethorphan (promethazine hydrochloride, dextromethorphan hydrobromide) Syrup, ANI Pharma, Manufacturing Change or Addition
Update : 6
Subject: Civil Penalties Sought Against Maker of Hearing Aid
Civil Penalties Sought Against Maker of Hearing Aid
Fri, 4 Apr 2008 10:08:00 -0500
A hearing aid manufacturer breaks the law, and FDA is seeking more than $2 million in penalties
Update : 7
Subject: U.S. Food & Drug Administration (FDA) CBER's Proposed and Final Rules Update
You are subscribed to CBER's Proposed and Final Rules for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.
Amendment to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals; Withdrawal
Posted: 4/4/2008; Publish Date: 4/4/2008
Update : 8
Subject: CDER New 4/4/2008
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April 4, 2008
- CDER Key Officials
- National Drug Code Directory Download (updated)
- National Drug Code Directory Search (updated)
Update : 9
Subject: Federal Agents Seize Nearly $1.3 Million of Illegal Dietary Supplements
Federal Agents Seize Nearly $1.3 Million of Illegal Dietary Supplements
Fri, 4 Apr 2008 15:14:00 -0500
At the request of the U.S. Food and Drug Administration, on Wednesday U.S. Marshals seized more than $1,301,712 of dietary supplements from LG Sciences, LLC, of Brighton, Mich., because the products contain unapproved food additives and/or new dietary ingredients that cause the products to violate the law. Labeled as dietary supplements, the products are marketed for use by body builders.
Update : 10
Subject: FDA Data Standards Update - SPL Terminology Update: SPL Flavors
Greetings,
The FDA Data Standards Council's SPL web page was updated Friday, April 4, 2008, to include a list of flavors to be utilized in SPL documents.
The new terms and codes are located on this web page: http://www.fda.gov/oc/datacouncil/term.html#flavor.
Lonnie Smith
Project Manager
Food and Drug Administration
Update : 11
Subject: Harry and David Issues Nationwide Allergy Alert on Undeclared Milk in Harry and David Chocolate Covered Select Blend Espresso Beans (April 4)
Harry and David Issues Nationwide Allergy Alert on Undeclared Milk in Harry and David Chocolate Covered Select Blend Espresso Beans (April 4)
Fri, 4 Apr 2008 18:45:00 -0500
Harry and David is recalling 8 oz. bags of Chocolate Covered Select Blend Espresso Beans with "Best if used by" dates after 8/28/05, sold prior to April 5th, 2008. The "Best if used by" date is located in the lower right hand corner of the nutrition label on the back of the bag. Bags subject to this recall do NOT have a "Contains milk, soy" statement on the nutrition label. These products are packaged in 8 oz. clear plastic bags, tied at the top with a tan ribbon.
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