Drugs
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Drug Alerts and Statements
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Alerts
FDA advises healthcare providers to visually inspect Hospira Carpuject pre-filled cartridges for overfill
5/23/2012FDA Reminds the Public about the Potential for Life-Threatening Harm from Accidental Exposure to Fentanyl Transdermal Systems (“Patches”)
4/18/2012Certain Opiate Products Made for Endo Pharmaceuticals
1/9/2012FDA Alerts Pharmacists and Health Care Professionals to Potential for Injury when Dispensing the Similar-Sounding Drugs Durezol and Durasal
12/28/2011FDA Alerts Health Care Professionals of Infection Risk from Repackaged Avastin Intravitreal Injections
8/30/2011Letter to Healthcare Professionals: Communication on lansoprazole delayed-release orally disintegrating tablets manufactured by Teva Pharmaceuticals
4/15/2011Advisory to Drug Manufacturers: Formation of Glass Lamellae in Certain Injectable Drugs
3/25/2011Letter to Stakeholders: Communication on certain needleless pre-filled glass syringes
11/17/2010Advisory to Drug and Dietary Supplement Manufacturers, Compounding Pharmacies and Distributors of Excipients and Dietary Ingredients – FDA Detects High Levels of Peroxide in Crospovidone
10/21/2010FDA Public Health Alert: Potential Medication Errors with Tamiflu for Oral Suspension
9/25/2009FDA Public Health Alert: Healthcare Professionals Warned Not To Use Certain Intravenous Metronidazole, Ondansetron, and Ciprofloxacin Due To Potential Contamination
6/1/2010
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Statements
FDA Notification to the Cystic Fibrosis Community on Kalydeco (ivacaftor)
8/29/2012Notice to Industry: Draft Guidance for Over-the-Counter Products that Contain Acetaminophen
7/3/2012FDA Statement regarding azithromycin (Zithromax) and the risk of cardiovascular death
5/17/2012Statement from the Center for Drug Evaluation and Research on the IOM Report: Ethical and Scientific Issues in Studying the Safety of Approved Drugs, released May 1, 2012
5/1/2012- Updated: FDA Issues Second Warning to Physicians about Certain Compounded Drugs from Franck’s
4/20/2012 - Another cancer medicine determined to be counterfeit - Illegal practice by doctors puts patients at risk.
4/3/2012 FDA Warns Physicians about Using Brilliant Blue G for Eye Surgery
3/19/2012FDA Statement about Product Quality of Parenteral Vancomycin Products
3/9/2012Counterfeit Version of Avastin in U.S. Distribution
2/14/2012WHO warns consumers in Pakistan of risks associated with contaminated medicines
2/10/2012FDA Statement on recently terminated clinical trial with Doribax (doripenem)
1/5/2012Ben Venue Laboratories – Voluntary Shutdown
11/30/2011Statement from FDA Commissioner Margaret Hamburg, M.D. and Assistant Secretary for Health Howard Koh, M.D., M.P.H. on Drug Shortages
9/9/2011Notification to Pharmaceutical Companies: Acceptance of third-party data integrity audit for Cetero studies conducted from March 1, 2008 to August 31, 2009
7/26/2011FDA Statement on Dexrazoxane
7/20/2011FDA Notification to Industry Regarding Potential Adulteration of Pharmaceutical Ingredients used as Emulsifying Agents and Flavorings
6/18/2011FDA Statement on the AIM-HIGH Trial
5/26/2011Chantix: Quarterwatch Article
5/19/2011Important Notice to IRBs Reviewing FDA-Regulated Research
1/27/2011FDA reminder to avoid concomitant use of Plavix (clopidogrel) and omeprazole
10/27/2010FDA Statement on ASBMR report: Possible Increased Risk of Certain Types of Thigh Bone Fractures with Long-Term Bisphosphonates Use
9/14/2010Midodrine Update
9/10/2010FDA Statement on Avandia TIDE Trial
7/21/2010Letter: Response to concerns on injectable Vitamin C and other injectable nutrients
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