Renal Business Today

Recalls

Omontys Recalled: Affymax, Takeda Looking for Root Cause

On Sunday, February 24, Omontys (peginesatide), which was approved in March 2012 by the U.S. Food and Drug Administration (FDA), was voluntarily recalled by Affymax and Takeda due to reports of fatalities and severe hypersensitivity reactions. Since the incident, Affymax ...More
March 8, 2013
Posted in Articles, Business
Affymax CEO Discusses Omontys Recall

PALO ALTO, Calif.— Affymax CEO John Orwin spoke up February 25 regarding the voluntary recall of its FDA-approved anemia drug Omontys (peginesatide). ...More
February 27, 2013
Posted in News, Business
Affymax, Takeda Recall Omontys Due to Reactions, Deaths

PALO ALTO, Calif.— Affymax Inc. and Takeda Pharmaceuticals are voluntarily recalling all lots of the anemia drug Omontys after reports of fatalities and anaphylaxis, a life-threatening allergic reaction. ...More
February 25, 2013
Posted in News, Business
FDA Places GranuFlo, NaturaLyte Under Serious Recall Category

NEW YORK—GranuFlo and NaturaLyte, both dialysis concentrates have been classified by the FDA as Class I recall products, placing them in the agency's most serious medical device recall category. ...More
June 29, 2012
Posted in News, Government & Regulation
Vitaflo Recalls Renastart Cans Due to Possible Health Risk

ALEXANDRIA, Va.―Vitaflo USA today announced a voluntary recall of Renastart 14.11 oz (400g) cans, batch number 12832 (shown on underside of can), because some of the product shipped throughout the United States during the period December 29, 2011, through January 26, 2012, ...More
February 1, 2012
Posted in News, Business
American Regent Recalls Lot of Sodium Chloride Injection

WASHINGTON—American Regent initiated on June 14 a voluntary nationwide recall of one lot of its concentrated sodium chloride injection due visible particulates. ...More
June 16, 2011
Posted in News, Clinical & Pharma, Government & Regulation
Fresenius Recalls Blood Tubing Set Due to Kinks

WALTHAM, Mass.—Fresenius Medical Care North America (FMCNA) has started a voluntary recall of specific lots of a blood tubing set due to kinks in the line. ...More
January 17, 2011
Posted in News, Business, Government & Regulation, Practice Management
FDA Recalls Millions of Diabetes Test Strips

The U.S. Food and Drug Administration is working with Abbott Diabetes Care to recall 359 lots of glucose test strips because they may falsely give low blood glucose results. ...More
December 28, 2010
Posted in Blog, Government & Regulation
B. Braun Recalls 7 Lots of Possibly Tainted Heparin

B. Braun Medical has recalled seven lots of heparin due to the possibility they were tainted. ...More
October 28, 2010
Posted in Blog, Government & Regulation
Amgen Recalls Epogen, Procrit Due to Glass Flakes

THOUSAND OAKS, Calif.—Amgen has issued a voluntary recall of certain lots of the anemia drugs Epogen and Procrit because they could contain thin glass flakes, according to a Sept. 24 news release. ...More
September 24, 2010
Posted in News, Clinical & Pharma, Government & Regulation