Title 21 Code of Federal Regulations 640.120(a) - The Director, Center for Biologics Evaluation and Research, may approve an exception or alternative procedures to any requirement in subchapter F (Biologics) of Chapter I (Parts 600 - 680) of title 21 of the Code of Federal Regulations regarding blood, blood components or blood products. Both licensed and unlicensed blood establishments must submit requests for an exception or alternative procedure to the requirements in Parts 600-680.

Kategorien: Sicherheitsinformationen - Arzneimittel und Medizinprodukte

List of Establishments Granted Approval for a Variance to 21CFR640.3(d) and 21CFR640.3(f)

1. Mai 2012 - 12:51

Kategorien: Sicherheitsinformationen - Arzneimittel und Medizinprodukte

Influenza Virus Vaccine for the 2011 - 2012 Season

19. April 2012 - 15:36

Cumulative 2010/2011 Season Lot Release Status (Updated 10/20/2010)

Kategorien: Sicherheitsinformationen - Arzneimittel und Medizinprodukte

Influenza Virus Vaccine for the 2010-2011 Season

19. April 2012 - 15:21

Cumulative 2010/2011 Season Lot Release Status (Updated 10/20/2010)

Kategorien: Sicherheitsinformationen - Arzneimittel und Medizinprodukte

Twinrix

16. April 2012 - 13:20

Update for Hepatitis A, Inactivated and Hepatitis B (Recombinant) Vaccine, Twinrix®, Package Insert to include additional adverse events. Posted: 12/11/2009

Kategorien: Sicherheitsinformationen - Arzneimittel und Medizinprodukte

Moon Marine USA Corporation voluntarily recalls frozen raw yellowfin tuna product “Nakaochi Scrape” associated with a multistate outbreak of Salmonella Bareilly infections

14. April 2012 - 4:56

Moon Marine USA Corporation (also known as MMI) of Cupertino, Calif. is voluntarily recalling 58,828 lbs of a frozen raw yellowfin tuna product, labeled as Nakaochi Scrape AA or AAA. Nakaochi Scrape is tuna backmeat, which is specifically scraped off from the bones, and looks like a ground product. The product is not available for sale to individual consumers, but may have been used to make sushi, sashimi, ceviche and similar dishes available in restaurants and grocery stores.

Kategorien: Sicherheitsinformationen - Arzneimittel und Medizinprodukte

PHOTO - Mission Foods Voluntarily Recalls Taco Dinner Kits Due to Possible Undeclared Milk Allergen

14. April 2012 - 3:58

Kategorien: Sicherheitsinformationen - Arzneimittel und Medizinprodukte

Mission Foods Voluntarily Recalls Taco Dinner Kits Due to Possible Undeclared Milk Allergen

14. April 2012 - 3:55

Mission Foods announced today a voluntary recall of its Taco Dinner Kits distributed by Kroger, Winn-Dixie, Hannaford and Food Lion because they may contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.

Kategorien: Sicherheitsinformationen - Arzneimittel und Medizinprodukte

Moon Marine USA Corporation voluntarily recalls frozen raw yellowfin tuna product

14. April 2012 - 0:48

• Moon Marine USA Corporation (also known as MMI) of Cupertino, Calif. is voluntarily recalling 58,828 lbs of a frozen raw yellowfin tuna product, labeled as Nakaochi Scrape AA or AAA. Nakaochi Scrape is tuna backmeat, which is specifically scraped off from the bones, and looks like a ground product. • The product is not available for sale to individual consumers, but may have been used to make sushi, sashimi, ceviche and similar dishes available in restaurants and grocery stores. • The company name and Nakaochi Scrape AA or AAA were printed on boxes of the product when it was initially sold to distributors. However, the boxes may have been broken into smaller lots for further sale and may not be available to the end retailer or consumer. Therefore, the tuna may not be readily identifiable by retail outlets or by consumers as being from the implicated lots. • The Nakaochi Scrape AA and AAA from MMI was sold through distributors to restaurants and grocery stores that make sushi, and has been linked to an outbreak of Salmonella Bareilly, which has caused 116 illnesses in 20 states and the District of Columbia to date. Of the reported illnesses, there have been 12 hospitalizations, and no deaths. • Many of the people who became ill reported eating raw tuna in sushi as “spicy tuna.” • If you purchase “spicy tuna” or other sushi, sashimi, ceviche, or similar dishes that might contain Nakaochi Scrape from a restaurant or grocery store, check with the establishment to make sure that it does not contain raw recalled product from Moon Marine USA Corporation, also known as MMI. When in doubt, don’t eat it. • Consumers who think they might have become ill from eating possibly contaminated raw Nakaochi Scrape should consult their health care providers.

Kategorien: Sicherheitsinformationen - Arzneimittel und Medizinprodukte

Harry and David Issues Allergy Alert on Undeclared Peanuts in Harry & David Premium Kansas City Style Barbeque Almonds

14. April 2012 - 0:14

Harry and David, is voluntarily recalling approximately 205 2 oz. bags labeled Harry & David Premium Kansas City Style Barbeque almonds, because the bags may contain peanuts. Peanuts are not declared as ingredients, but the label includes the statement "May contain trace amounts of allergens not listed in the ingredients."Â

Kategorien: Sicherheitsinformationen - Arzneimittel und Medizinprodukte