Safety Alerts
November 2019
Class 2 Medicines Recall: Ranitidine Oral Solution 30mg/ml, PL 31862/0023, Ranitidine 150mg Tablets. See below link for more information.
https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-ranitidine-oral-solution-30mg-ml-pl-31862-0023-ranitidine-150mg-tablets-pl-11311-0138-el-19-a-36?utm_source=94f04dab-dfe6-4ab0-bfa1-59a9031468a4&utm_medium=email&utm_campaign=govuk-notifications&utm_content=immediat
Class 2 Medicines Recall: M&A Pharmachem Limited Paracetamol 500 mg Tablets, 1 x 1000, PL 04077/0001, See below link for more information:
https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-m-a-pharmachem-limited-paracetamol-500-mg-tablets-1-x-1000-pl-04077-0001-el-19-a-32?utm_source=164a4947-6565-4a11-bcfb-78e3787d6a4d&utm_medium=email&utm_campaign=govuk-notifications&utm_content=immediate
Safety Alerts 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:
https://www.gov.uk/drug-device-alerts/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-?utm_source=fa8ff23a-1ada-4004-985c-ef0364c08aa3&utm_medium=email&utm_campaign=govuk-notifications&utm_content=immediate
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 | |
| | BUK901 | 04/2022 | 1 x 12 | 17 June 2019 |
Montelukast (Singulair): reminder of the risk of neuropsychiatric reactions
See patient leaflet: https://assets.publishing.service.gov.uk/media/5d8245e940f0b61cde2724fa/PIL-Sept-201.pdf
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.
Aripiprazole 1mg/ml oral solution PL 08553/0582
Batch Number Expiry Date Pack Size First Distributed 050618 05/2020 150ml 13 July 2018
Brief description of problem Dr. Reddy's Laboratories (UK) Ltd is recalling the above batch due to the potential for small particles of Aripiprazole active material to be present which may affect the efficacy of the product. A product complaint has been received by the company from the UK market, relating to the formation of a precipitate in a bottle of product.