Safety Alerts MHRA

Safety Alerts 2019/20

January 2020

DHSC, PHE and NHS England experts are closely monitoring the outbreak of a novel coronavirus in Wuhan, China. If you have travelled to the affected area, make sure you know what to do if you experience symptoms:


December 2019

Emerade 150 micrograms solution for injection in pre-filled syringe   PL 33616/0013

Emerade 300 micrograms solution for injection in pre-filled syringe   PL 33616/0014

Emerade 500 micrograms solution for injection in pre-filled syringe   PL 33616/0015

Recalling all unexpired batches of the above product due an error in one component of the autoinjector believed to cause some pens to fail to activate and deliver adrenaline. More information is provided.   Emerade stock held by patients is not being recalled, and patients and caregivers in possession of Emerade pens need to be informed of updated safety information about the risk of failure to activate.


Class 2 Medicines recall: Ranitidine 150mg Film-Coated Tablets, PL 20075/0063, Ranitidine 300mg Film-Coated Tablets, PL 20075/0064 (EL(19)A/40)

Ranitidine 150mg Film-Coated Tablets PL 20075/0063

Ranitidine 150mg Film-Coated Tablets PL 20075/0063  

Ranitidine 300mg Film-Coated Tablets PL 20075/0064  

Accord Healthcare are recalling all unexpired stock of the above products from pharmacies and wholesalers as a precautionary measure due to possible contamination with an impurity Nnitrosodimethylamine (NDMA) which has genotoxic and carcinogenic potential.

November 2019

Class 2 Medicines Recall: Ranitidine Oral Solution 30mg/ml, PL 31862/0023, Ranitidine 150mg Tablets. See below link for more information.


Class 2 Medicines Recall: M&A Pharmachem Limited Paracetamol 500 mg Tablets, 1 x 1000, PL 04077/0001, See below link for more information:


October 2019

Class 2 Medicines recall: Zantac 75 Relief Tablets, Zantac 75 Tablets, Galpharm Indigestion Relief 75mg Tablets, Boots Heartburn & Indigestion Relief 75mg Tablets, Kirkland Indigestion Relief 75mg Tablets, Morrisons Indigestion & Heartburn Relief 75mg Tablets, Boots Heartburn & Indigestion Relief 75mg Tablets (EL (19)A/30) See below link for more information:



September 2019

Class 2 Medicines Recall: Bisacodyl 10mg Suppositories EL (19)A/22

Product description

Bisacodyl 10mg Suppositories

Batch number/expiry


Batch Number

Expiry Date

Pack Size

First Distributed





1 x 12

17 June 2019


Montelukast (Singulair): reminder of the risk of neuropsychiatric reactions

See patient leaflet:


Elmiron (pentosan polysulfate sodium): rare risk of pigmentary maculopathy.

Cases of pigmentary maculopathy leading to visual impairment have been reported with pentosan polysulfate, particularly after long-term use at high doses. Patients taking pentosan polysulfate should have regular ophthalmic examinations and should promptly seek medical advice in case of visual changes

Fingolimod (Gilenya): increased risk of congenital malformations; new contraindication during pregnancy and in women of childbearing potential not using effective contraception


Fingolimod is associated with an increased risk of major congenital malformations including cardiac, renal, and musculoskeletal defects, when used in pregnancy. Women of childbearing potential must use effective contraception during fingolimod treatment and for 2 months after discontinuation.


Hormone replacement therapy (HRT): further information on the known increased risk of breast cancer with HRT and its persistence after stopping


New data have confirmed that the risk of breast cancer is increased during use of all types of HRT, except vaginal estrogens, and have also shown that an excess risk of breast cancer persists for longer after stopping HRT than previously thought.




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