Recall Class: Class I Date Recall Initiated: March 26, 2010 Product: Symbiq Infusion System Brand Name: Symbiq One-Channel Infuser Symbiq Two-Channel Infuser Model Numbers:16026 Symbiq One-Channel Infuser16027 Symbiq Two-Channel Infuser Dates of Distribution: December 23, 2006 – January 22, 2010 All lots are affected and can be found in the following List Number Configurations: Use:…
Safety Investigation of Patient Burns Associated with Electric Dental Handpieces and Electric Oral Bone-cutting Handpieces
Date issued:Sept 23, 2010 Audiences:Dentists, Dental Hygienists, Dental Assistants Devices: Electric dental handpieces and electric oral bone-cutting handpieces are AC-powered hand-held devices used to prepare dental cavities for restorations, such as fillings, and for cleaning teeth. For the purposes of this communication, is the term “handpiece†includes the motor, contrangle, and burr. SUMMARY OF PROBLEM…
Draft Guidance for Industry and FDA Staff
DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Document issued on: September 23, 2010 You should submit comments and suggestions regarding this draft document within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit written comments to the Division of Dockets…
August 30, 2010 Clarification Letter
Our STN: BL 125254/132 CSL LimitedAttention: Paul Hartmann, R.Ph.1020 First AvenueP.O. Box 61501 King of Prussia, PA 19406-0901 Dear Mr. Hartmann: The purpose of this letter is to clarify your pediatric study fulfillment requirements that were omitted from our approval letter, dated November 10, 2009. Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c),…
Gadolinium-based Contrast Agents: Class Labeling Change
Ablavar (gadofosveset trisodium), Eovist (gadoxetate disodium), Magnevist (gadopentetate dimeglumine), Multihance (gadobenate dimeglumine), Omniscan (gadodiamide), Optimark (gadoversetamide injection), Prohance (gadoteridol) Â [Posted 09/09/2010] AUDIENCE: Radiology, Nephrology, Dermatology ISSUE: FDA is requiring changes in the professional labeling for gadolinium-based contrast agents (GBCAs) to minimize the risk of nephrogenic systemic fibrosis (NSF), a rare, but serious, condition associated…
Hospira Symbiq One-Channel and Two-Channel Infusers: Class I Recall
[UPDATED 09/21/2010] There is potential for unrestricted flow of fluid or medication if the administration set (cassette) is removed before the cassette carriage fully opens and the slide/roller clamp is not closed. Additionally, when unrestricted flow occurs, the â??Check Flow Stopâ? alarm, which is designed to notify users of a free flow condition, may not…
National Drug Code Directory
The NDC serves as universal product identifier for human drugs. Update frequency: Semimonthly Search National Drug Code Directory Download Data Files (Data Files Updated through 9/15/2010) What are the NDC Number and the National Drug Code Directory? The Drug Listing Act of 1972 requires registered drug establishments to provide the Food and Drug Administration (FDA)…
Electronic Orange Book (EOB) Query data files
The following describes the Approved Drug Products EOB Query web files. The files are ASCII text tilde (~) delimited. They are zipped into a file: EOBZIP.ZIP (Last updated 9/20/2010) Allow for approximately 5 megabytes for the unzip process. 1.     PRODUCTS.TXT Tilde (~) delimited Orange Book approved products: Ingredient The active ingredient(s) for the product….
FDA Drug Safety Communication: Ongoing Safety Review of Actos (pioglitazone) and Potential Increased Risk of Bladder Cancer After Two Years Exposure
 Safety AnnouncementAdditional Information for PatientsAdditional Information for Healthcare ProfessionalsData SummaryReferences  Safety Announcement [09-17-2010] The U.S. Food and Drug Administration (FDA) is reviewing data from an ongoing, ten-year epidemiological study designed to evaluate whether Actos (pioglitazone), is associated with an increased risk of bladder cancer. Findings from studies in animals and humans suggest this…