U.S. Food and Drug Administration Updates for Health Professionals
As part of our ongoing efforts to keep you informed about FDA issues, we want to make you are aware of recent safety alerts, product approvals, announcements, upcoming meetings, and resources. We have included a list of the issues, a brief summary of each issue, and links to detailed information on the FDA Web site.
PRODUCT SAFETY:
West-Ward Pharmaceuticals Inc., of Eatontown, NJ, is voluntarily recalling all lots of Claris LifeSciences Inc. manufactured Ondansetron in 5% Dextrose Injection, supplied in 32mg/50mL Single-Use Plastic Bag Containers and Metronidazole Injection 500mg/100ml USP in Flexible IV Plastic Bag Containers. Claris recently received reports of the presence of floating matter and non-sterility in Ondansetron and Metronidazole. Non-sterile products administered intravenously may cause infections which could be fatal especially in patients who are immuno-compromised.
Pfizer Initiates a Nationwide Voluntary Recall of All Lots of Metronidazole Injection,
Ciprofloxacin Injection, and Ondansetron Injection Bags Made by Claris Lifesciences
Due to Non-Sterility (June 3)
Pfizer Inc is voluntarily recalling Metronidazole, Ciprofloxacin and Ondansetron IV Products due to the presence of floating matter and non-sterility discovered by the manufacturer Claris Laboratories.
Hospira, Inc. announced today it is voluntarily expanding its March 31, 2010, recall of Propofol Injectable Emulsion 1% and Liposyn™ (Intravenous Fat Emulsion) products which include Liposyn II 10%, Liposyn II 20%, Liposyn III 10%, Liposyn III 20%, and Liposyn III 30% to the consumer or user level. Hospira is conducting the recall because some of the containers may contain particulate matter. The particulate is primarily made up of sub-visible inert stainless steel particles.
PediaCare Children's Products [Blacksmith Brand]: Recall of four products (May 28)
Blacksmith Brands and FDA notified healthcare professionals and patients about a nationwide recall of all lots of four PediaCare children's products. These products are sold exclusively in the United States and were manufactured by McNeil Consumer Healthcare at McNeil's Fort Washington, PA plant.
FDA warned consumers not to purchase or use a product called “Arrow Brand Medicated Oil & Embrocation,” also labeled as “Aceite Medicinal La Flecha (Spanish) or “箭嘜驅風油 (Chinese).” The product is potentially toxic and contains two substances, methyl salicylate and camphor, which are poisonous when ingested.
For more product safety information, please visit our MedWatch website.
PRODUCT APPROVALS:
FDA Approves New Injectable Osteoporosis Treatment for Postmenopausal Women (June 1)
FDA approved Prolia, an injectable treatment for postmenopausal women with osteoporosis who are at high risk for fractures.
For more information on drug approvals, please visit Drugs@FDA.
ANNOUNCEMENTS:
FDA Announces Collaboration with Drugs.com (May 26)
Goal is to expand online distribution of Agency’s consumer health information
Center for Devices and Radiologic Health Using Twitter
FDA's Center for Devices and Radiological Health is adding the social media site Twitter to its communication and outreach program. CDRH's main goal for Twitter is to reach regulated industry, health professionals, and others interested in the business of the center in a way convenient to them.