{"id":567186,"date":"2010-05-17T17:25:48","date_gmt":"2010-05-17T21:25:48","guid":{"rendered":"http:\/\/www.xconomy.com\/?p=80409"},"modified":"2010-05-17T17:25:48","modified_gmt":"2010-05-17T21:25:48","slug":"glass-flakes-in-vials-prompt-halozyme-baxter-to-recall-hylenex-pediatric-rehydration-product","status":"publish","type":"post","link":"https:\/\/mereja.media\/index\/567186","title":{"rendered":"Glass Flakes in Vials Prompt Halozyme, Baxter to Recall Hylenex Pediatric Rehydration Product"},"content":{"rendered":"\n
Recalls<\/a>, Life Sciences<\/a>, Quality Control<\/a><\/div>\n

\t\t\"halozyme<\/a>
\n\t\tBruce V. Bigelow wrote:<\/strong><\/p>\n

First San Diego’s Cadence Pharmaceuticals (NASDAQ: CADX<\/a>), and now, Halozyme Therapeutics (NASDAQ: HALO<\/a>), have encountered troubles resulting from contaminated biomedical products coming from their manufacturing partner, Baxter Healthcare, a unit of Baxter International (NYSE: BAX<\/a>) of Deerfield, IL.<\/p>\n

Today Halozyme and Baxter said they are voluntarily recalling affected lots of a product called Hylenex<\/a> that is used to treat pediatric dehydration after discovering glass flakes in “a limited number of vials.”<\/p>\n

In a statement, Halozyme says no “medical events” associated with glass particles in vials of Hylenex have been reported, and the recall is being taken as a precautionary measure to ensure patient safety. Baxter says the contamination affects some 3,500 vials in distribution.<\/p>\n

As Denise reported in February, Cadence suffered a setback<\/a> in its efforts to win FDA approval for its intravenous form of acetaminophen (the pain reliever used in Tylenol and other products) after an FDA inspection identified numerous deficiencies in a Baxter plant in Cleveland, MS, that was preparing to manufacture the product. After meeting with the FDA in April, and resubmitting its filing for a new drug application for its IV painkiller, called Ofirmev, the FDA said it would act on Nov. 4, according to Cadence<\/a>.<\/p>\n

Halozyme said earlier today it had notified Baxter Health that it had breached the terms of its supply contract. Halozyme said<\/a> if Baxter is unable to address the contamination issue within 120 days, it may terminate the contract.<\/p>\n

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Recalls, Life Sciences, Quality Control Bruce V. Bigelow wrote: First San Diego’s Cadence Pharmaceuticals (NASDAQ: CADX), and now, Halozyme Therapeutics (NASDAQ: HALO), have encountered troubles resulting from contaminated biomedical products coming from their manufacturing partner, Baxter Healthcare, a unit of Baxter International (NYSE: BAX) of Deerfield, IL. Today Halozyme and Baxter said they are voluntarily […]<\/p>\n","protected":false},"author":5423,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[7],"tags":[],"class_list":["post-567186","post","type-post","status-publish","format-standard","hentry","category-news"],"_links":{"self":[{"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/posts\/567186","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/users\/5423"}],"replies":[{"embeddable":true,"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/comments?post=567186"}],"version-history":[{"count":0,"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/posts\/567186\/revisions"}],"wp:attachment":[{"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/media?parent=567186"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/categories?post=567186"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/tags?post=567186"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}