From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 28 Jul 2008 08:03:37 -0500 (CDT)
Subject: CDRH New Update
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| FDA Home Page | CDRH Home Page | Search | A-Z Index |  | |
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 | Date: July 28, 2008 |
The following new items were added to the CDRH web pages on July 25, 2008. Previous CDRH New Items can be found on the CDRHNew Page.
 | Summary Information for: Access® Hybritech® PSA reagents on the Access® Immunoassay Systems |  | |
| Consumer Information on: EVOLENCE® Collagen Filler - P070013 |  |
Update: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 28 Jul 2008 10:04:08 -0500 (CDT)
Subject: Jack Distribution, LLC. Issues a Voluntary Nationwide Recall of all Lots of Rize 2 The Occasion Capsules and Rose 4 Her Capsules, Products Marketed as Dietary Supplements, Containing an Undeclared Ingredient(July 28)
Jack Distribution, LLC. Issues a Voluntary Nationwide Recall of all Lots of Rize 2 The Occasion Capsules and Rose 4 Her Capsules, Products Marketed as Dietary Supplements, Containing an Undeclared Ingredient(July 28)
Mon, 28 Jul 2008 09:20:00 -0500
Jack Distribution, LLC, and its wholesale distributors G and N works, Inc., and Devine Distribution, Inc., announced today that they are conducting a voluntary nationwide recall of all lot numbers of the company's supplement products sold under the brand names Rize 2 The Occasion and Rose 4 Her. New lots of Rize 2 and Rose 4 her (not subject to this recall) will contain lot numbers beginning in "BL".
Update: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 28 Jul 2008 11:18:57 -0500 (CDT)
Subject: CDER New 7/25/2008
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July 25, 2008
- Accelerated Approvals under 21 CFR 314 Subpart H (drugs) and 21 CFR 601 Subpart E (biologics) (updated)
- Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated)
- New and Generic Drug Approvals
- Capastat Sulfate (capreomycin sulfate) Injection, Eli Lilly and Co., Labeling Revision
- Exforge (amlodipine besylate and valsartan) Tablets, Novartis Pharmaceuticals Corp., New or Modified Indication
- Oxycodone Hydrochloride Extended-Release Tablets, Mallinckrodt, Inc., Approval
- Simcor (niacin and simvastatin) Extended-Release Tablets, Abbott Laboratories, Labeling Revision
- Strattera (atomoxetine hydrochloride) Capsules, Eli Lilly and Co., Efficacy Supplement with Clinical Data to Support
- Strattera (atomoxetine hydrochloride) Capsules, Eli Lilly and Co., Labeling Revision
Update: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 28 Jul 2008 12:02:55 -0500 (CDT)
Subject: Vita Food Products Issues Alert Regarding Vita Nova Salmon (July 25)
Vita Food Products Issues Alert Regarding Vita Nova Salmon (July 25)
Mon, 28 Jul 2008 11:51:00 -0500
The product that is the subject of this public announcement and recall are packages (deep dark blue in color) of smoked salmon that bear the Vita logo in the upper left corner on the part of the packaging that is immediately visible to the consumer. Each package contains 4-10 bacon-style slices (total 3 oz.) of smoked salmon; the slices are contained in a vacuum pack within a box that is 4" wide by 7.5" in length by 1/2" in thickness. IMPORTANT: The Code Date of 11/16/08 198 is on the left end flap of each package. This announcement and recall only applies to packages that bear that CODE DATE.
Update: 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 28 Jul 2008 12:18:16 -0500 (CDT)
Subject: FDA Data Standards Update - Revised SPL Stylesheet (v4.02)
Greetings,
The FDA Data Standards Council's SPL web page (http://www.fda.gov/oc/datacouncil/spl.html) was updated Monday, July 28, 2008, to include the following information:
Revised SPL Release Four Stylesheet (v4.02)
Lonnie Smith
Project Manager
Structured Product Labeling Team
Medical Informatics Staff &
FDA Data Standards Council
Update: 6
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 28 Jul 2008 16:03:18 -0500 (CDT)
Subject: FDA Advises Against Consumption of American Lobster (Maine Lobster) Tomalley
FDA Advises Against Consumption of American Lobster (Maine Lobster) Tomalley
Mon, 28 Jul 2008 15:29:00 -0500
The U.S. Food and Drug Administration today warned consumers to avoid eating tomalley in American Lobster (Maine Lobster), regardless of where the lobster was harvested, because of potential contamination with dangerous levels of the toxins that cause Paralytic Shellfish Poisoning (PSP).
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