Jim Vititoe | May 5, 2010
What products are affected by this recall?
The products include certain liquid infant’s and children’s Tylenol Motrin, Zyrtec, and Benadryl products. For a complete list of recalled products, please see http://www.mcneilproductrecall.com/page.jhtml?id=/include/new_recall.inc
Why were these products recalled?
McNeil Consumer Healthcare is initiating this voluntary recall because some of these products may not meet required quality standards. As a precautionary [...]
Category: FDA, Health Alert |
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Jim Vititoe | April 29, 2010
Safety Announcement
02-22-2010] The U.S. Food and Drug Administration (FDA) is reviewing data, submitted in August 2009, from a large, long-term clinical study on possible risks with the diabetes drug, Avandia* (rosiglitazone). The clinical study, called the Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes or RECORD study was designed to evaluate [...]
Category: FDA, Health Alert, Medical Warning |
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Jim Vititoe | March 24, 2010
FOR IMMEDIATE RELEASE - March 12, 2010 - Limerick, PA - Teleflex Incorporated provided an update today on the previously announced Arrow International, Inc. voluntary recall of ALL lots of its Arrow custom intravenous administration products (IV tubing sets and accessories) and certain Arrow arterial embolectomy catheters distributed prior to February 19, 2010.
Testing revealed [...]
Category: Health Alert, Medical Recall, Medical Warning |
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Tags: compromised packaging
Jim Vititoe | March 24, 2010
FDA NEWS RELEASE
For Immediate Release: March 22, 2010
Media Inquiries: Shelly Burgess, 301-796-4651; shelly.burgess@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
Components of Extraneous Virus Detected in Rotarix Vaccine; No Known Safety Risk
FDA Recommends Clinicians Temporarily Suspend Use of Vaccine as Agency Learns More
FDA is recommending that healthcare practitioners temporarily suspend use of the Rotarix vaccine for rotavirus immunization in the United [...]
Category: FDA, Health Alert, Medical Recall, Medical Warning |
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Jim Vititoe | January 25, 2010
Contact:
Darrall Pride
978-232-3957 x 110
FOR IMMEDIATE RELEASE - January 21, 2010 - Hettich Centrifuges, Beverly, MA, is initiating a North America and Canada recall of 2050 and 2076 plastic hematocrit rotors that are used in combination with the Mikro 12-24, Mikro 20, Haematokrit 20 and Haematokrit 24 bench top plastic centrifuges. These plastic rotors have the [...]
Category: Health Alert, Medical Recall, Medical Warning |
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Jim Vititoe | January 25, 2010
Contact:
Jessica Oswald
305.599.7174 x249
(EST: 9 am – 5 pm)
FOR IMMEDIATE RELEASE - January 21, 2010 - Nipro Medical Corporation, Miami FL, is initiating a nationwide recall of all GlucoPro Insulin Syringes (This does not include the GlucoPro syringe specific for use with the Amigo Insulin pump). These syringes may have needles that detach from the syringe. [...]
Category: Health Alert, Medical Recall, Medical Warning |
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Jim Vititoe | January 11, 2010
Endovascular, Inc. and FDA notified healthcare professionals of a Class I Recall of the Trailblazer Support Catheter. This device may crack near the radiopaque marker band. This may result in serious patient injury, including insufficient oxygen supply to the tissues, damage to blood vessels, heart attack, limb amputation, unplanned surgery, and/or death. See the Recall [...]
Category: Health Alert, Medical Recall, Medical Warning |
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Jim Vititoe | January 11, 2010
Consumer Questions:
1-888-222-6036
(Monday-Friday 8 a.m. to 8 p.m. Eastern Time, and Saturday-Sunday 9 a.m. to 5 p.m. Eastern Time)
Media Contacts:
Marc Boston
215-273-7649 (office)
215-429-7034 (mobile)
Bonnie Jacobs
215-273-8994 (office)
856-912-9965 (mobile)
FOR IMMEDIATE RELEASE – December 18, 2009 – Fort Washington, PA – In consultation with the U.S. Food and Drug Administration (FDA), McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc., is [...]
Category: FDA, Health Alert, Medical Recall, Medical Warning |
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Tags: 2, 4, 6-tribromoanisole, contamination
Jim Vititoe | January 11, 2010
Company Contact:
Victoria Young
214-948-5940
FOR IMMEDIATE RELEASE – December 26, 2009 – McDonough, GA – Jea R. Gackowski, Encompass Group Corporate Compliance Officer announced today the company is voluntarily recalling the Thermoflect product line for relabeling regarding its use in the MR (Magnetic Resonance) environment.
“We are voluntarily recalling the product line from use in the Magnetic Resonance [...]
Category: FDA, Health Alert, Medical Recall, Medical Warning |
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Tags: injury risk
Jim Vititoe | October 7, 2009
Neuron 6F 070 Delivery Catheter [Penumbra]
Voluntary Field Removal
Audience: interventional neuroradiology healthcare professionals, hospital risk managers
[UPDATED 10/07/2009] Recall classified as Class I.
[Posted 10/01/2009] Penumbra and FDA notified healthcare professionals about a voluntary field removal of the original version of Neuron 6F 070 Delivery Catheter due to reports that the catheter could kink or ovalize in certain [...]
Category: Consumer Alert, Health Alert, Medical Recall, Recall |
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Tags: flawed