Biotechnology Dashboard

Tri-union Seafoods Expands Recall To Include Chunk Light Tuna In Oil Products

2013-03-08T12:31:00.002-08:00

White Star/Chicken of the Sea Tuna Ad, 1953 (Photo credit: alsis35)

U.S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
Food Safety Alerts

Tri-union Seafoods Expands Recall To Include Chunk Light Tuna In Oil Products

Tri-Union Seafoods LLC, which previously announced a voluntary recall, is now expanding it to include a limited amount of Chicken of the Sea brand 5-ounce chunk light tuna in oil. This is in addition to the limited amount of Chicken of the Sea brand 5-ounce chunk white albacore tuna in water announced March 6, 2013.

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Tri-union Seafoods Expands Recall To Include Chunk Light Tuna In Oil Products

2013-03-08T12:31:00.001-08:00

U.S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
Food Safety Alerts

Tri-union Seafoods Expands Recall To Include Chunk Light Tuna In Oil Products

Food Safety Alerts are also available at:
http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/FoodSafety/rss.xml

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Update of CVM's What's New - Updated Listing of Veterinary Feed Directive Distributor Notifications

2013-03-08T12:15:00.001-08:00

You are subscribed to CVM What's New, for newly posted information on the U.S. Food & Drug Administration's (FDA) Center for Veterinary Medicine's (CVM) Website.

This information has recently been updated and is now available.

Updated Listing of Veterinary Feed Directive Distributor Notifications – http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/ucm071807.htm

Visit our home page at http://www.fda.gov/AnimalVeterinary/default.htm

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Drug Information Update - Changes in the Office of Prescription Drug Promotion

2013-03-08T11:59:00.003-08:00

The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.

Dear Colleague:

In follow-up to the announcement below concerning changes in the Office of Prescription Drug Promotion, please see the updated list of reviewers and their new assignments: OPDP Organization Listing

Sincerely,

Office of Prescription Drug Promotion

I would like to make you aware of changes in the Office of Prescription Drug Promotion (OPDP), Office of Medical Policy. OPDP works to protect the public health by ensuring that all prescription drug promotional labeling and advertising directed to health care professionals and consumers is truthful, balanced, and not misleading.

Recently, OPDP reviewed and analyzed the workload and review processes in its two divisions, the Division of Consumer Drug Promotion, and the Division of Professional Drug Promotion, in an effort to improve upon their overall impact and effectiveness. The goal of this analysis was to increase efficiency, improve work distribution, and eliminate redundancy. Through the analysis, OPDP concluded that a structure that integrates the review of health care professional-directed and consumer-directed promotion across the two divisions would meet this goal.

Toward this goal, OPDP will be restructuring its divisions and, pending final approval, will rename them the Division of Advertising and Promotion Review I and the Division of Advertising and Promotion Review II. Both divisions will handle health care and consumer promotion. As a way to distribute the work evenly, each division will oversee different therapeutic classes of drugs. These changes will allow OPDP to review direct-to-consumer (DTC) and health professional advertising more effectively.

We know that DTC advertising is often the catalyst for patients initiating conversations with their physicians about their untreated or undertreated conditions. It is also a subject of interest and debate among our stakeholders. The decision to restructure the divisions reflects our commitment to continue providing close oversight of DTC advertising. The new structure will improve efficiency in our program area and our ability to meet the health needs of the American public.

Our ODPD reviewers will continue to use a comprehensive surveillance, enforcement, and education program to foster superior communication of labeling and promotional information to both health care professionals and consumers.

Janet Woodcock

This is an automated message delivery system. Replying to this message will not reach DDI staff. If you have comments or questions, please contact us at: 1-888-INFO FDA (1-888-463-6332) or (301) 796-3400 from 8:00 am - 4:30 pm Monday - Friday. You can also email us at druginfo@fda.hhs.gov.

For additional drug information, please visit the DDI Web page.
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Drug Information Update - Changes in the Office of Prescription Drug Promotion

2013-03-08T11:59:00.001-08:00

The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.

Dear Colleague:

Sincerely,

Office of Prescription Drug Promotion

Janet Woodcock

For additional drug information, please visit the DDI Web page.
For up-to-date drug information, follow the FDA’s Division of Drug Information on Twitter: FDA_Drug_Info
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Steve’s Real Food Recalls Turducken Canine Recipe Patties Because of Posssible Health Risk

2013-03-08T11:06:00.001-08:00

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Steve’s Real Food Recalls Turducken Canine Recipe Patties Because of Posssible Health Risk

03/08/2013 01:45 PM EST

Steve’s Real Food of Murray, Utah is recalling its 5 lb. bags of "Turducken Canine Diet – 8oz. Patties due to potential contamination of Salmonella.

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Tri-union Seafoods Expands Recall To Include Chunk Light Tuna In Oil Products

2013-03-08T11:06:00.000-08:00

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Tri-union Seafoods Expands Recall To Include Chunk Light Tuna In Oil Products

03/08/2013 01:22 PM EST

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Steve’s Real Food Recalls Turducken Canine Recipe Patties Because of Posssible Health Risk

2013-03-08T11:05:00.003-08:00

You are subscribed to Recalls, Market Withdrawals and Safety Alerts for U.S. Food & Drug Administration (FDA).

This information has recently been updated and is now available.

Steve’s Real Food Recalls Turducken Canine Recipe Patties Because of Posssible Health Risk

03/08/2013 01:45 PM EST

Steve’s Real Food of Murray, Utah is recalling its 5 lb. bags of "Turducken Canine Diet – 8oz. Patties due to potential contamination of Salmonella.

. For detailed information pertaining to this Recalls, Market Withdrawals and Safety Alerts message, please click the link at the beginning of this bulletin.

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Tri-union Seafoods Expands Recall To Include Chunk Light Tuna In Oil Products

2013-03-08T11:05:00.001-08:00

You are subscribed to Recalls, Market Withdrawals and Safety Alerts for U.S. Food & Drug Administration (FDA).

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Tri-union Seafoods Expands Recall To Include Chunk Light Tuna In Oil Products

03/08/2013 01:22 PM EST

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Update of CVM's What's New - Steve’s Real Food Recalls Turducken Canine Recipe Patties Because of Possible Health Risk

2013-03-08T11:04:00.001-08:00

You are subscribed to CVM What's New, for newly posted information on the U.S. Food & Drug Administration's (FDA) Center for Veterinary Medicine's (CVM) Website.

This information has recently been updated and is now available.

Steve’s Real Food Recalls Turducken Canine Recipe Patties Because of Possible Health Risk – http://www.fda.gov/Safety/Recalls/ucm342902.htm

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U.S. Food & Drug Administration (FDA) Medication Guides Update

2013-03-08T10:47:00.001-08:00

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The FDA Medication Guides page has been updated and is now available at http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm.

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Drug Information Update - FDA issues draft guidance for manufacturers to accurately label medical products that are not made with natural rubber latex

2013-03-08T09:48:00.002-08:00

The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.

The U.S. Food and Drug Administration today issued draft recommendations to medical product manufacturers for providing consumers with accurate information about products that are not made with natural rubber latex (NRL).

NRL is a milky fluid found in rubber trees and other plant sources. Prolonged or repeated exposure to NRL can result in sensitivity or allergy. Mild reactions may include skin redness, rash, hives, or itching. More severe reactions may include respiratory symptoms such as difficulty breathing, coughing spells and wheezing. Rarely, anaphylactic shock may occur.

The FDA is encouraging manufacturers of FDA-regulated medical products to stop using statements on labels such as “latex free” or “does not contain natural rubber latex” because these statements are not scientifically accurate. Instead, the FDA recommends manufacturers use the labeling statement – “not made with natural rubber latex” – to indicate when NRL was not used as a material in the medical product or product container.

For more information, please visit: Manufacturers of products not made with natural rubber latex

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Drug Information Update - FDA issues draft guidance for manufacturers to accurately label medical products that are not made with natural rubber latex

2013-03-08T09:48:00.001-08:00

The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.

For more information, please visit: Manufacturers of products not made with natural rubber latex

For additional drug information, please visit the DDI Web page.
For up-to-date drug information, follow the FDA’s Division of Drug Information on Twitter: FDA_Drug_Info
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FDA issues draft guidance for manufacturers to accurately label medical products that are not made with natural rubber latex

2013-03-08T07:26:00.003-08:00

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FDA issues draft guidance for manufacturers to accurately label medical products that are not made with natural rubber latex

03/08/2013 09:42 AM EST

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FDA issues draft guidance for manufacturers to accurately label medical products that are not made with natural rubber latex

2013-03-08T07:26:00.001-08:00

You are subscribed to FDA Press Releases for U.S. Food & Drug Administration (FDA).

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FDA issues draft guidance for manufacturers to accurately label medical products that are not made with natural rubber latex

03/08/2013 09:42 AM EST

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There's No Guarantee of 'Latex Free'

2013-03-08T07:24:00.001-08:00

Receive this email from someone else? Subscribe now!

There's No Guarantee of 'Latex Free'

03/08/2013 09:00 AM EST

To avoid giving a false sense of security to people who are allergic to natural rubber latex, FDA is recommending that manufacturers of FDA-regulated medical products stop using statements on labels such as "latex-free" or "does not contain latex." FDA is aware of no tests that can show a medical product is completely without the natural rubber latex proteins that can cause allergic reactions.

Read this Consumer Update to learn more about who is at risk of allergic reactions to natural rubber latex and what you can do to prevent such reactions.

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Changes in the Office of Prescription Drug Promotion

2013-03-08T07:12:00.001-08:00

Dear Colleague:

Sincerely,

Office of Prescription Drug Promotion

Janet Woodcock

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Watch: Tokumei Sentai Go-Busters vs. Kaizoku Sentai Gokaiger: The Movie (2013) DVDRip 300MB Free Movies

2013-03-08T05:53:00.002-08:00

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Tokumei Sentai Go-Busters vs. Kaizoku Sentai Gokaiger: The Movie (2013) DVDRip 300MB Free Movies

Mar 8th 2013, 07:18

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CDER New March 8, 2013

2013-03-08T05:18:00.001-08:00

What's New on the FDA Drugs Site

March 7, 2013

2012-2013 Influenza Season: Availability of Antivirals (updated)
Current Drug Shortages Index (updated)

March 6, 2013

Drug Firm Annual Registration Status Download File (updated)
Drug Firm Annual Registration Status (updated)
Drugs@FDA Data Files (updated)
National Drug Code Directory (updated)
Pediatric Exclusivity Statistics (updated)

New and Generic Drug Approvals

March 6, 2013

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Amyvid	florbetapir f-18	Solution; Intravenous	Avid Radiopharms Inc	Manufacturing Change or Addition
Cerebyx	fosphenytoin sodium	Injectable; Injection	Parke Davis	Labeling Revision
Dilantin	phenytoin sodium	Injectable; Injection	Parke Davis	Labeling Revision
Dilantin-125	phenytoin	Suspension; Oral	Parke Davis	Labeling Revision
Dilantin-30	phenytoin	Suspension; Oral	Parke Davis	Labeling Revision
Lioresal	baclofen	Injectable; Intrathecal	Medtronic	Manufacturing Change or Addition
Silvadene	silver sulfadiazine	Cream; Topical	King Pharms	Labeling Revision
Tegretol	carbamazepine	Tablet; Oral	Novartis	Labeling Revision
Tegretol	carbamazepine	Tablet, Chewable; Oral	Novartis	Labeling Revision
Tegretol	carbamazepine	Suspension; Oral	Novartis	Labeling Revision
Tegretol-Xr	carbamazepine	Tablet, Extended Release; Oral	Novartis	Labeling Revision
Zometa	zoledronic acid	Injectable; Iv (Infusion)	Novartis	Manufacturing Change or Addition

March 5, 2013

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Aggrastat	tirofiban hydrochloride	Injectable; Injection	Medicure	Manufacturing Change or Addition
Firmagon	degarelix acetate	Powder; Subcutaneous	Ferring	Labeling Revision
Lexiva	fosamprenavir calcium	Tablet; Oral	Viiv Hlthcare	Manufacturing Change or Addition
Oravig	miconazole	Tablet; Buccal	Vestiq Pharms	Labeling Revision

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U.S. Food & Drug Administration (FDA) CVM FR Notices Update

2013-03-08T05:13:00.001-08:00

You are subscribed to CVM FR Notices for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.

http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/ucm216453.htm

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CDRH New Update

2013-03-08T04:52:00.002-08:00

CDRHNew

Date: March 8, 2013

The following new items were added to the CDRH web pages on March 7, 2013. Previous CDRH New Items can be found on the CDRHNew Page.

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CDRH New Update

2013-03-08T04:52:00.001-08:00

CDRHNew

Date: March 8, 2013

The following new items were added to the CDRH web pages on March 7, 2013. Previous CDRH New Items can be found on the CDRHNew Page.

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Bumble Bee Foods Expands Voluntary Recall on Specific Codes of 5-Ounce Chunk White Albacore and Chunk Light Tuna Products Due to Loose Seals

2013-03-08T01:51:00.003-08:00

You are subscribed to Recalls, Market Withdrawals and Safety Alerts for U.S. Food & Drug Administration (FDA).

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Bumble Bee Foods Expands Voluntary Recall on Specific Codes of 5-Ounce Chunk White Albacore and Chunk Light Tuna Products Due to Loose Seals

03/07/2013 11:33 PM EST

Bumble Bee Foods, LLC, is expanding a voluntary recall on specific codes of 5-ounce Chunk White Albacore and Chunk Light Tuna products. The recall has been issued because the products do not meet the company's standards for seal tightness.

. For detailed information pertaining to this Recalls, Market Withdrawals and Safety Alerts message, please click the link at the beginning of this bulletin.

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Bumble Bee Foods Expands Voluntary Recall on Specific Codes of 5-Ounce Chunk White Albacore and Chunk Light Tuna Products Due to Loose Seals

2013-03-08T01:51:00.001-08:00

You are subscribed to Recalls, Market Withdrawals and Safety Alerts for U.S. Food & Drug Administration (FDA).

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Bumble Bee Foods Expands Voluntary Recall on Specific Codes of 5-Ounce Chunk White Albacore and Chunk Light Tuna Products Due to Loose Seals

03/07/2013 11:33 PM EST

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2013-03-07T23:19:00.003-08:00

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Tri-union Seafoods Expands Recall To Include Chunk Light Tuna In Oil Products

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CDRH New Update

CDRHNew

Date: March 8, 2013

CDRH New Update

CDRHNew

Date: March 8, 2013

Bumble Bee Foods Expands Voluntary Recall on Specific Codes of 5-Ounce Chunk White Albacore and Chunk Light Tuna Products Due to Loose Seals

Bumble Bee Foods Expands Voluntary Recall on Specific Codes of 5-Ounce Chunk White Albacore and Chunk Light Tuna Products Due to Loose Seals

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