{"id":44593,"date":"2016-09-09T00:00:00","date_gmt":"2016-09-09T04:00:00","guid":{"rendered":"https:\/\/asweetlife.org\/novo-nordisk-recalls-six-batches-of-glucagen-hypokit-glucagon-rdna-origin-for-injection\/"},"modified":"2016-10-14T07:12:13","modified_gmt":"2016-10-14T11:12:13","slug":"novo-nordisk-recalls-six-batches-of-glucagen-hypokit-glucagon-rdna-origin-for-injection","status":"publish","type":"post","link":"https:\/\/asweetlife.org\/?p=44593","title":{"rendered":"Novo Nordisk Recalls Six Batches of GlucaGen HypoKit (glucagon [rDNA origin] for injection)"},"content":{"rendered":"<p class=\"p1\" style=\"text-align: justify;\"><a href=\"https:\/\/asweetlife.org\/news\/novo-nordisk-recalls-six-batches-of-glucagen-hypokit-glucagon-rdna-origin-for-injection\/attachment\/novo-nordisk-logo-33\/\" rel=\"attachment wp-att-39157\"><img decoding=\"async\" class=\"size-full wp-image-39157 alignleft lazyload\" src=\"data:image\/gif;base64,R0lGODlhAQABAAAAACH5BAEKAAEALAAAAAABAAEAAAICTAEAOw==\" data-src=\"https:\/\/asweetlife.org\/wp-content\/uploads\/2016\/09\/Novo-Nordisk-Logo.png\" alt=\"novo-nordisk-logo\" width=\"215\" height=\"160\" \/><\/a><\/p>\n<p class=\"p3\" style=\"text-align: justify;\"><span class=\"s1\">Novo Nordisk Inc. is recalling six batches of the GlucaGen<\/span><span class=\"s1\">\u00a0HypoKit<\/span><span class=\"s1\">\u00a0in the U.S. due to two customer complaints from the UK and Portugal involving detached needles on the syringe with Sterile Water for Injection (SWFI). GlucaGen<\/span><span class=\"s1\">\u00a0HypoKit<\/span><span class=\"s1\">\u00a0is indicated for the treatment of severe hypoglycemia (low blood sugar) in patients with diabetes who are treated with insulin. A syringe with a detached needle cannot be used as prescribed.<\/span><\/p>\n<p class=\"p3\" style=\"text-align: justify;\"><span class=\"s1\">Untreated hypoglycemia can eventually lead to unconsciousness and seizures, which can prove fatal. If the blood glucose levels are not quickly restored, continuing hypoglycemia can lead to a decline in brain glucose levels which manifests through a variety of symptoms including cognitive dysfunction, sweating, tremors, convulsion and eventually coma or death.<\/span><\/p>\n<p class=\"p3\" style=\"text-align: justify;\"><span class=\"s1\">Novo Nordisk conducted an investigation which showed that a small number (0.006%) of needles could be detached from the syringe in certain batches of GlucaGen<\/span><span class=\"s1\">\u00a0HypoKit<\/span><span class=\"s1\">. To protect patient safety, Novo Nordisk is recalling affected batches from wholesalers, pharmacies and patients in the U.S. \u00a0It is estimated that out of the 71,215 pens being recalled, four pens could be defective.<\/span><\/p>\n<p class=\"p3\" style=\"text-align: justify;\"><span class=\"s1\">This recall includes GlucaGen<\/span><span class=\"s5\"><sup>\u00ae<\/sup><\/span><span class=\"s1\"> HypoKit<\/span><span class=\"s5\"><sup>\u00ae<\/sup><\/span><span class=\"s1\"> batch numbers:<\/span><\/p>\n<ul class=\"ul1\" style=\"text-align: justify;\">\n<li class=\"li3\"><span class=\"s1\">Batch: FS6X270, Expiry: 09\/30\/2017<\/span><\/li>\n<li class=\"li3\"><span class=\"s1\">Batch: FS6X296, Expiry: 09\/30\/2017<\/span><\/li>\n<li class=\"li3\"><span class=\"s1\">Batch: FS6X538, Expiry: 09\/30\/2017<\/span><\/li>\n<li class=\"li3\"><span class=\"s1\">Batch: FS6X597, Expiry: 09\/30\/2017<\/span><\/li>\n<li class=\"li3\"><span class=\"s1\">Batch: FS6X797, Expiry: 09\/30\/2017<\/span><\/li>\n<li class=\"li3\"><span class=\"s1\">Batch: FS6X875, Expiry: 09\/30\/2017<\/span><\/li>\n<\/ul>\n<p class=\"p3\" style=\"text-align: justify;\"><span class=\"s1\">The affected products were distributed starting February 15, 2016.<\/span><\/p>\n<p class=\"p3\" style=\"text-align: justify;\"><span class=\"s1\">Novo Nordisk is working as quickly as possible and in collaboration with the U.S. Food and Drug Administration (FDA) to recall affected products from the marketplace, including those in the possession of patients. To date, Novo Nordisk is not aware of any known adverse events resulting from the use of the recalled batches.<\/span><\/p>\n<p class=\"p3\" style=\"text-align: justify;\"><span class=\"s1\">Patients or caregivers should check the batch number to see if their GlucaGen<\/span><span class=\"s5\"><sup>\u00ae<\/sup><\/span><span class=\"s1\"> HypoKit<\/span><span class=\"s5\"><sup>\u00ae<\/sup><\/span><span class=\"s1\"> is affected. The batch number is printed on the GlucaGen<\/span><span class=\"s5\"><sup>\u00ae<\/sup><\/span><span class=\"s1\"> HypoKit<\/span><span class=\"s5\"><sup>\u00ae<\/sup><\/span><span class=\"s1\"> as indicated below in the red box (Figure 1).<\/span><\/p>\n<p class=\"p3\" style=\"text-align: justify;\"><a href=\"https:\/\/asweetlife.org\/news\/novo-nordisk-recalls-six-batches-of-glucagen-hypokit-glucagon-rdna-origin-for-injection\/attachment\/novo-glucogen-kit\/\" rel=\"attachment wp-att-39156\"><img decoding=\"async\" class=\"aligncenter size-full wp-image-39156 lazyload\" src=\"data:image\/gif;base64,R0lGODlhAQABAAAAACH5BAEKAAEALAAAAAABAAEAAAICTAEAOw==\" data-src=\"https:\/\/asweetlife.org\/wp-content\/uploads\/2016\/09\/Novo-GlucoGen-Kit.jpg\" alt=\"novo-glucogen-kit\" width=\"400\" height=\"269\" \/><\/a><\/p>\n<p class=\"p3\" style=\"text-align: justify;\"><span class=\"s1\"><b>Figure 1.<\/b> A) GlucaGen<\/span><span class=\"s1\">\u00a0HypoKit<\/span><span class=\"s1\">\u00a0where the batch number is found in the red box, B) close up of the batch number.<\/span><\/p>\n<p class=\"p3\" style=\"text-align: justify;\"><span class=\"s1\"><b>If you have a GlucaGen<span style=\"font-size: 10px; line-height: 10px;\">\u00a0<\/span><\/b><\/span><span class=\"s1\"><b>\u00a0HypoKit<span style=\"font-size: 10px; line-height: 10px;\">\u00a0<\/span><\/b><\/span><span class=\"s1\"><b>with one of the above-mentioned batch numbers, call 1-888-840-1137 from Monday to Friday, between 8:30am \u2013 6:00pm Eastern Time, to find out how to return the product.\u00a0 Novo Nordisk will provide reimbursement for out-of-pocket costs incurred for the purchase for your affected GlucaGen<\/b><\/span><span class=\"s5\"><b><sup>\u00ae<\/sup><\/b><\/span><span class=\"s1\"><b> HypoKit<\/b><\/span><span class=\"s5\"><b><sup>\u00ae<\/sup><\/b><\/span><span class=\"s1\"><b> with proof of purchase. If you received a GlucaGen<\/b><\/span><span class=\"s5\"><b><sup>\u00ae<\/sup><\/b><\/span><span class=\"s1\"><b> HypoKit<\/b><\/span><span class=\"s5\"><b><sup>\u00ae<\/sup><\/b><\/span><span class=\"s1\"><b> through the Novo Nordisk Patient Assistance Program, you will receive a replacement device.<\/b><\/span><\/p>\n<p class=\"p3\" style=\"text-align: justify;\"><span class=\"s1\">If you are in possession of a GlucaGen<\/span><span class=\"s1\">\u00a0HypoKit<\/span><span class=\"s1\">\u00a0with a batch number <\/span><span class=\"s2\"><b>NOT<\/b><\/span><span class=\"s1\"> mentioned above, the product is not subject to the recall and may be used as prescribed.<\/span><\/p>\n<p class=\"p3\" style=\"text-align: justify;\"><span class=\"s1\">Novo Nordisk Inc. is notifying its distributors and customers by letter and phone and is arranging for return of all recalled products.<\/span><\/p>\n<p class=\"p3\" style=\"text-align: justify;\"><span class=\"s1\">Adverse reactions or quality problems experienced with the use of this product may be reported to Novo Nordisk by calling 1-800-727-6500.\u00a0 Patients can also call the FDA&#8217;s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.<\/span><\/p>\n<ul class=\"ul1\" style=\"text-align: justify;\">\n<li class=\"li3\"><span class=\"s1\">Complete and submit the report <b>Online<\/b>: <a href=\"http:\/\/www.fda.gov\/medwatch\/report.htm\" target=\"_blank\"><span class=\"s4\">www.fda.gov\/medwatch\/report.htm<\/span><\/a><\/span><\/li>\n<li class=\"li3\"><b><\/b><span class=\"s1\"><b>Regular Mail or Fax<\/b>: Download form <a href=\"http:\/\/www.fda.gov\/MedWatch\/getforms.htm\" target=\"_blank\"><span class=\"s4\">www.fda.gov\/MedWatch\/getforms.htm<\/span><\/a> or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.<\/span><\/li>\n<\/ul>\n<p class=\"p3\" style=\"text-align: justify;\"><span class=\"s1\">This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>&hellip;<\/p>\n","protected":false},"author":131,"featured_media":44594,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_relevanssi_hide_post":"","_relevanssi_hide_content":"","_relevanssi_pin_for_all":"","_relevanssi_pin_keywords":"","_relevanssi_unpin_keywords":"","_relevanssi_related_keywords":"","_relevanssi_related_include_ids":"","_relevanssi_related_exclude_ids":"","_relevanssi_related_no_append":"","_relevanssi_related_not_related":"","_relevanssi_related_posts":"","_relevanssi_noindex_reason":"","footnotes":""},"categories":[1443],"tags":[899],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v22.9 (Yoast SEO v22.9) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Novo Nordisk Recalls Six Batches of 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