Baxter International Inc. (NYSE:BAX) announced today that a voluntary recall of all manufactured lots of HYLENEX recombinant (hyaluronidase human injection) has been initiated as a precautionary measure due to instances of particulate matter observed in a limited number of HYLENEX vials during routine stability testing. Baxter is working with the … [Read more...]

RECALLS, MARKET WITHDRAWALS, & SAFETY ALERTS ARCHIVE FOR RECALLS, MARKET WITHDRAWALS & SAFETY ALERTS ENFORCEMENT REPORTS INDUSTRY GUIDANCE MAJOR PRODUCT RECALLS VAR CID_ID, CID_ITEM, CID_CLASS, CONTENT_PAGE = 0; VAR BREAKOUT = FALSE; VAR CID = WINDOW.LOCATION.HREF.SPLIT("/"); VAR CID_FILENAME = CID; IF(CID_FILENAME.TOLOWERCASE() == "DEFAULT.HTM" || … [Read more...]

Sagent Pharmaceuticals, Inc. announced the voluntary nationwide recall of all lots of metronidazole injection, USP 500mg / 100mL manufactured by Claris Lifesciences and distributed by Sagent due to the discovery of non-sterility in two lots of metronidazole injection. Non-sterility of an antimicrobial administered via the intravenous route has the … [Read more...]

COMPANY CONTACT: JAKE ELGUICZE,  VICE PRESIDENT INVESTOR RELATIONS TEL: 610-948-2836   RESEARCH TRIANGLE PARK, NC - TELEFLEX MEDICAL HAS ANNOUNCED A WORLDWIDE VOLUNTARY RECALL INITIATED ON MARCH 19, 2010, AFFECTING CERTAIN LOT NUMBERS OF THE TELEFLEX MEDICAL AQUA+FLEX HYGROSCOPIC CONDENSER HUMIDIFIER (HCH) (CATALOG NUMBER 1570) A PASSIVE … [Read more...]

RECALLS, MARKET WITHDRAWALS, & SAFETY ALERTS ARCHIVE FOR RECALLS, MARKET WITHDRAWALS & SAFETY ALERTS ENFORCEMENT REPORTS INDUSTRY GUIDANCE MAJOR PRODUCT RECALLS - RECALL -- FIRM PRESS RELEASE   FDA POSTS PRESS RELEASES AND OTHER NOTICES OF RECALLS AND MARKET WITHDRAWALS FROM THE FIRMS INVOLVED AS A SERVICE TO CONSUMERS, THE MEDIA, AND OTHER … [Read more...]