{"id":1282,"date":"2018-01-17T15:16:57","date_gmt":"2018-01-17T15:16:57","guid":{"rendered":"https:\/\/www.groupactionlawyers.co.uk\/blog\/?p=1282"},"modified":"2018-01-17T15:16:57","modified_gmt":"2018-01-17T15:16:57","slug":"histamine-alert-gentamicin-sulphate-active-pharmaceutical-ingredient","status":"publish","type":"post","link":"https:\/\/www.groupactionlawyers.co.uk\/blog\/histamine-alert-gentamicin-sulphate-active-pharmaceutical-ingredient","title":{"rendered":"MHRA issues warning for Gentamicin Sulphate Active Pharmaceutical Ingredient over increased levels of histamine"},"content":{"rendered":"<p>The Medicines and Healthcare products Regulatory Agency (MHRA) has issued an alert over batches of <em>Gentamicin Sulphate Active Pharmaceutical Ingredient<\/em> (API) for trace contamination of histamine.<\/p>\n<p>The situation is reportedly not serious enough to warrant a recall.<\/p>\n<p>Gentamicin is a bactericidal used an as active ingredient for antibiotics. The MHRA was made aware that testing of the finished products has uncovered higher levels of histamine than expected. The unwanted histamine is thought to be a residual from the manufacturing process, with the potentially affected range between July 2014 and June 2017.<br \/>\n<!--more--><br \/>\nWhile a recall has not been deemed necessary, healthcare professionals still need to keep the alert in mind. This may be especially important when using a Gentamicin drug along with medicines that cause histamine release, like opioids and muscle relaxants. It has been reported that the combination of Gentamicin with non-polarising muscle relaxants could cause <strong>neuromuscular blockage and respiratory paralysis<\/strong>.<\/p>\n<p>If you have an allergy, you may be aware of anti-histamines. Histamines initiate our bodies to react and repel allergens by sneezing it out or getting it off your skin by making you itchy. However, our bodies can overreact to a point where we need to take antihistamines to calm the histamines down.<\/p>\n<p>In this case, increased levels of histamines may cause similar reactions. Patients taking the Gentamicin products with heightened levels of histamines may therefore experience the following adverse reactions:<\/p>\n<div class=\"well\">\n<ul class=\"blog-list\">\n<li>Flushing<\/li>\n<li>Itching<\/li>\n<li>Urticaria (rashes or hives)<\/li>\n<li>Shortness of breath<\/li>\n<li>Hypotensive reactions<\/li>\n<li>Increased heart rate<\/li>\n<li>Increased blood pressure<\/li>\n<\/ul>\n<\/div>\n<p>Those who suffer from kidney problems may reportedly be more susceptible to adverse effects so these patients must be closely monitored.<\/p>\n<p>The below chart contains information from the MGRA on the products that may be affected by the alert:<\/p>\n<div class=\"table-responsive\">\n<table class=\"table table-bordered table-striped\">\n<thead>\n<tr>\n<th>Marketing Authorisation Holder<\/th>\n<th>Product<\/th>\n<th>PL Number<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>B Braun Melsungen AG<\/td>\n<td>Gentamicin 1mg\/ml Solution for Infusion<\/td>\n<td>03551\/0116<\/td>\n<\/tr>\n<tr>\n<td>B Braun Melsungen AG<\/td>\n<td>Gentamicin 3mg\/ml Solution for Infusion<\/td>\n<td>03551\/0117<\/td>\n<\/tr>\n<tr>\n<td>Sanofi<\/td>\n<td>Cidomycin (Gentamicin) 80mg\/2ml Solution for Injection<\/td>\n<td>04425\/0672<\/td>\n<\/tr>\n<tr>\n<td>Hospira UK Limited<\/td>\n<td>Gentamicin40mg\/ml Injection<\/td>\n<td>04515\/0037<\/td>\n<\/tr>\n<tr>\n<td>Zentiva<\/td>\n<td>Gentamicin Intrathecal 5mg\/ml Solution for Injection<\/td>\n<td>17780\/0506<\/td>\n<\/tr>\n<tr>\n<td>Zentiva<\/td>\n<td>Gentamicin Paediatric 20mg\/2ml Solution for Injection<\/td>\n<td>17780\/0507<\/td>\n<\/tr>\n<tr>\n<td>Amdipharm UK Limited<\/td>\n<td>Gentamicin 40mg\/ml Solution for Injection<\/td>\n<td>20072\/0056<\/td>\n<\/tr>\n<tr>\n<td>Wockhardt UK Limited<\/td>\n<td>Gentamicin 10mg\/ml Solution for Injection or Infusion<\/td>\n<td>29831\/0659<\/td>\n<\/tr>\n<tr>\n<td>Wockhardt UK Limited<\/td>\n<td>Gentamicin 40mg\/ml Solution for Injection or Infusion<\/td>\n<td>29831\/0660<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>The Medicines and Healthcare products Regulatory Agency (MHRA) has issued an alert over batches of Gentamicin Sulphate Active Pharmaceutical Ingredient (API) for trace contamination of histamine. The situation is reportedly not serious enough to warrant a recall. Gentamicin is a bactericidal used an as active ingredient for antibiotics. The MHRA was made aware that testing &hellip; <a href=\"https:\/\/www.groupactionlawyers.co.uk\/blog\/histamine-alert-gentamicin-sulphate-active-pharmaceutical-ingredient\" class=\"more-link\">Continue reading <span class=\"screen-reader-text\">MHRA issues warning for Gentamicin Sulphate Active Pharmaceutical Ingredient over increased levels of histamine<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":1286,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2},"jetpack_post_was_ever_published":false},"categories":[5],"tags":[20],"class_list":["post-1282","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medical","tag-mhra"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ 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Hospitals, pharmacies and other healthcare providers are requested to take\u2026","rel":"","context":"In &quot;Medical&quot;","block_context":{"text":"Medical","link":"https:\/\/www.groupactionlawyers.co.uk\/blog\/category\/medical"},"img":{"alt_text":"mhra alert","src":"https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/mhra-alert-min.png?fit=725%2C250&ssl=1&resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/mhra-alert-min.png?fit=725%2C250&ssl=1&resize=350%2C200 1x, https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/mhra-alert-min.png?fit=725%2C250&ssl=1&resize=525%2C300 1.5x, https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/mhra-alert-min.png?fit=725%2C250&ssl=1&resize=700%2C400 2x"},"classes":[]},{"id":1383,"url":"https:\/\/www.groupactionlawyers.co.uk\/blog\/focus-pharmaceuticals-barcode-errors-8-medicinal-products","url_meta":{"origin":1282,"position":1},"title":"MHRA issue &#8220;Class 4&#8221; drug alert warning for Focus Pharmaceuticals after barcode errors found on 8 medicinal products","author":"Admin","date":"21st February 2018","format":false,"excerpt":"The Medicines and Healthcare Products Regulatory Agency (MHRA) issued a Class 4 (caution in use) warning over eight Focus Pharmaceutical medicinal products after a problem was found with the barcodes. The packaging fault may interfere with prescriptions as the wrong product may be identified when they're scanned. The medicines themselves\u2026","rel":"","context":"In &quot;Medical&quot;","block_context":{"text":"Medical","link":"https:\/\/www.groupactionlawyers.co.uk\/blog\/category\/medical"},"img":{"alt_text":"barcode error alert","src":"https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/barcode-error-min.png?fit=725%2C250&ssl=1&resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/barcode-error-min.png?fit=725%2C250&ssl=1&resize=350%2C200 1x, https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/barcode-error-min.png?fit=725%2C250&ssl=1&resize=525%2C300 1.5x, https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/barcode-error-min.png?fit=725%2C250&ssl=1&resize=700%2C400 2x"},"classes":[]},{"id":525,"url":"https:\/\/www.groupactionlawyers.co.uk\/blog\/mirena-inserters-incorrectly-mounted-class-4-mhra-alert","url_meta":{"origin":1282,"position":2},"title":"Class 4 MHRA alert: Mirena inserters incorrectly mounted","author":"Admin","date":"14th February 2017","format":false,"excerpt":"Bayer plc, a global pharmaceutical company, has received two complaints with regards to its Mirena inserters. The complaints detail that the insertion tube was mounted inversely to the handle, and this has led to an inversion of the insertion depth scale, which may lead to incorrect insertion depth; consequently reducing\u2026","rel":"","context":"In &quot;Medical&quot;","block_context":{"text":"Medical","link":"https:\/\/www.groupactionlawyers.co.uk\/blog\/category\/medical"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/2016\/12\/medical.png?fit=725%2C250&ssl=1&resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/2016\/12\/medical.png?fit=725%2C250&ssl=1&resize=350%2C200 1x, https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/2016\/12\/medical.png?fit=725%2C250&ssl=1&resize=525%2C300 1.5x, https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/2016\/12\/medical.png?fit=725%2C250&ssl=1&resize=700%2C400 2x"},"classes":[]},{"id":849,"url":"https:\/\/www.groupactionlawyers.co.uk\/blog\/diclo-sr-75-pain-relief-tablets-class-2-recall","url_meta":{"origin":1282,"position":3},"title":"Class 2 recall for Diclo-SR 75 pain-relief tablets","author":"Admin","date":"28th July 2017","format":false,"excerpt":"A Watford-based pharmaceutical company has issued a voluntary recall for batches of Diclo-SR 75 pain relief tablets - AKA diclofenac sodium. The tablets are commonly used for pain relief and swelling for arthritis, musculoskeletal disorders, gout and pain caused by injury or minor surgery. The tablets are classified in a\u2026","rel":"","context":"In &quot;Medical&quot;","block_context":{"text":"Medical","link":"https:\/\/www.groupactionlawyers.co.uk\/blog\/category\/medical"},"img":{"alt_text":"pain relief tablets recall","src":"https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/pain-relief-tablets-recall-min.png?fit=725%2C250&ssl=1&resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/pain-relief-tablets-recall-min.png?fit=725%2C250&ssl=1&resize=350%2C200 1x, https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/pain-relief-tablets-recall-min.png?fit=725%2C250&ssl=1&resize=525%2C300 1.5x, https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/pain-relief-tablets-recall-min.png?fit=725%2C250&ssl=1&resize=700%2C400 2x"},"classes":[]},{"id":406,"url":"https:\/\/www.groupactionlawyers.co.uk\/blog\/chewy-calcium-vitamin-d-tablets-being-recalled-for-impurities","url_meta":{"origin":1282,"position":4},"title":"Chewy calcium and vitamin-D tablets are being recalled for impurities","author":"Admin","date":"28th December 2016","format":false,"excerpt":"Teva U.K. Limited - a global pharmaceutical company - has recalled a batch of class 2 medicines due to a possible metal contamination. The pharmaceutical company has recently made a precautionary batch recall for a 'small number' of Evacal D3 chewable tablets. The tablets are a calcium-vitamin D supplement used\u2026","rel":"","context":"In &quot;Medical&quot;","block_context":{"text":"Medical","link":"https:\/\/www.groupactionlawyers.co.uk\/blog\/category\/medical"},"img":{"alt_text":"drugs","src":"https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/2016\/11\/drugs-recall-750x250.png?fit=750%2C250&ssl=1&resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/2016\/11\/drugs-recall-750x250.png?fit=750%2C250&ssl=1&resize=350%2C200 1x, https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/2016\/11\/drugs-recall-750x250.png?fit=750%2C250&ssl=1&resize=525%2C300 1.5x, https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/2016\/11\/drugs-recall-750x250.png?fit=750%2C250&ssl=1&resize=700%2C400 2x"},"classes":[]},{"id":3187,"url":"https:\/\/www.groupactionlawyers.co.uk\/blog\/claiming-compensation-for-incorrect-dose-content-statement-in-flutiform-inhaler-recall","url_meta":{"origin":1282,"position":5},"title":"Claiming Compensation for Incorrect Dose Content Statement in Flutiform Inhaler Recall","author":"Author","date":"28th October 2025","format":false,"excerpt":"A recall of Flutiform 250 micrograms \/ 10 micrograms per actuation pressurised inhalation suspension by CD Pharma Ltd has highlighted a labelling error. This issue reportedly revolves around an incorrect dose content statement on the outer carton of specific batches, as notified to the MHRA. 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