Industry News: Page 265

Regulatory
Triad Sterile Lubricating Jelly: Recall - Product May Not Be Sterile
Product may be contained in kits, packs, or trays that have been packaged after December 2010 by other firms, including brand names Allegiance, Select Medical Products, Novaplus, Triad, Triad Plus, IMCO, McKesson Medi-Pak Performance, Henry Schein.
February 18, 2011
Regulatory
Fighting counterfeit drugs in Africa
Free consumer text messaging service targets counterfeit pharmaceutical market that causes at least 700,000 deaths per year globally.
February 18, 2011
Hp 19671 Loxagyl Scratch Off Codes Closeup
Regulatory
Hydrocodone Bitartrate And Acetaminophen Tablets, Phenobarbital Tablets by Qualitest: Recall - Incorrect Package Labeling
Individual bottle of Hydrocodone Bitatrate and Acetaminiphen tablets were incorrectly labeled with Phenobarbital Tablets. Both products are manufactured by Qualitest Pharmaceuticals.
February 15, 2011
Regulatory
FDA Compliant Stability Program In Changing Environment
From Tuesday, March 08 2011 - 8:00am to Thursday, March 10 2011 - 5:00pm (Eastern Time) Register Here
February 10, 2011
Regulatory
FDA Speaker Grace McNally to Present on USFDA's New Process Validation Guidance at ISPE 2011 Tampa Conference
Attendees of ISPE's 2011 Tampa Conference on Applying Solutions to Emerging Industry Challenges will have the chance to learn first-hand about the implications of the FDA's newly-updated Guideline on General Principles of Process Validation as part of one the event's educational sessions, "Pharmaceutical Inspections and Compliance - Current FDA Enforcement Trends."
February 4, 2011
Regulatory
Tainted products marketed as dietary suppliments potentially dangerous
In mid-December 2010, the U.S. Food and Drug Administration sent a letter to dietary supplement manufacturers regarding undeclared or deceptively labeled ingredients in products marketed as dietary supplements.
February 3, 2011
Regulatory
Lippke/Mocon Announces Permeation, Sterile Medical Packaging Conferences
Two new one-day packaging conferences have been announced by Paul Lippke Handels-GmbH, Neuwied, Germany, a wholly-owned division of MOCON, Inc. (NASDAQ: MOCO), Minneapolis, Minn., USA.
February 1, 2011
Regulatory
How to make 510(k)s more okay
FDA's new plan containing 25 actions for 2011 aims to improve the most common path to market for medical devices.
January 31, 2011
Hp 19637 I Stock Pda Med Device 000000363944 Small
Traceability/Serialization
COVECTRA offers serialization gateway for contract service providers
COVECTRA, a multi-layered brand protection solutions provider offering serialization, authentication, and track and trace technology services, today announced its new offering for Contract Service Providers (CSP) working in the pharmaceutical space.
January 26, 2011
Materials
FDA limits acetaminophen in prescription combination products; requires liver toxicity warnings
Agency strategy caps maximum at 325 milligrams to reduce risk of liver toxicity
January 25, 2011
Pharmaceuticals
Larger type, simplicity sought for labels
Labeling standards proposed at the U.S. Pharmacopeial meeting seek to help patients read and understand labels on medical containers.
January 19, 2011
Hp 19623 I Stock Label 000001144241 Small
Regulatory
December 2010 Safety Labeling Changes: 58 Medical Product Labels with changes to Boxed Warnings, Contraindications, Precautions, Adverse Reactions
The MedWatch December 2010 Safety Labeling Changes posting includes 58 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT PACKAGE INSERT, and MEDICATION GUIDE.
January 14, 2011
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