Archive for MHRA Updates
Medical device alerts archived in October 2021
Source: MHRA 7/10/21 Following our latest review of medical device alerts, we have archived the ones listed below. MDA/2017/015 Solus Flexible Wire Reinforced Laryngeal Mask Airway – risk of hypoxia...
Company led medicines recall: Glucose 10%w/v 10ml injection (unlicensed medicine) and Trometamol 7%w/v injection 5mL (unlicensed medicine)
Source: MHRA East Suffolk and North Essex NHS Foundation Trust (MS 12882) is recalling specific batches of Glucose 10%w/v injection 10mL and Trometamol 7%w/v injection 5mL due to limited assurance...
Class 2 Medicines Recall: Accord-UK Ltd (Trading style: NorthStar), LEVOTHYROXINE TABLETS BP 50 micrograms EL (21)A/23
Source: DHSC 27/9/21 Accord-UK Ltd (Trading style: NorthStar) are recalling the above batch of product as a precautionary measure due to tablet hardness failures, leading to crumbling and breaking tablets....
Class 4 Medicines Defect Information, Rosuvastatin 5 mg, 10 mg, 20 mg and 40 mg film-coated tablets (EL (21)A/21)
Accord Healthcare have informed us of an error with the patient information leaflets (PILs) that have been packaged in some Rosuvastatin products. Source: MHRA MDR Number MDR 197-08/21 Company name...
Batch of metformin oral solution recalled by MHRA due to nitrosamine impurity
Source: MHRA Patients should not stop any treatments without consulting their doctor or pharmacist. A recall notice for one batch (10,452 units) of metformin oral solution has today been...
Medicine Class 2 Recall
There has been a correction to this initial recall, by Aventis Pharma. Please click on this link to see the MHRA source
The Department of Health and Social Care has provided an update on the SSP for Fluoxetine 10mg tablets (SSP05)
Source: NHSBSA-SSP Update 10.08.2021 – The DHSC has provided an update on the Serious Shortage Protocols for Fluoxetine 10mg tablets (SSP05). This SSP has been varied – the revised end...
MHRA recalls contaminated Irbesartan- batches as precautionary measure
Patients should not stop any treatments without consulting their doctor or pharmacist Source: MHRA 9th August 2021 The MHRA today has issued a recall for 25 batches of Irbesartan-containing medicinal...
Field Safety Notices: 2 to 6 August 2021 List of field safety notices (FSNs) from medical device manufacturers from 2 to 6 August
Source: MHRA 9th August 2021 Overview If you receive a field safety notice (FSN) from a manufacturer you must always act on it. MHRA publishes the following for information only....
Class 2 Medicines Recall:Various Marketing Authorisation Holders and parallel distributor companies, Irbesartan-containing products, EL (21)A/19
Specific batches of products supplied by the Marketing Authorisation Holders and parallel distributor companies are being recalled due to presence of a mutagenic impurity. Source: MHRA 9th August 2021 Company...
Central Alert System- Tinzaparin Sodium Alert
Source: MHRA July 29, 2021 Unavailable From Mid October! MHRA has issued an alert via the Central Alert System for Tinzaparin sodium (10,000 IU/ml) 3,500 units in 0.35ml and 4,500...
Contractor Notice: SSP endorsement errors
Source: PSNC/ (NHSBSA) July 28, 2021 Following the announcement of the new Serious Shortage Protocols (SSP) endorsement which was introduced from 1 June 2021, PSNC has been working with NHS Business Services...
