-
Summary list of field safety notices (FSNs) from medical device manufacturers from 26 April to 30 April 2021
-
Lupin Healthcare (UK) Limited has informed us of a discrepancy with the product packaging for several batches of Syonell 250mg Gastro-Resistant Tablets and Syonell 500mg Gastro-Resistant Tablets. This discrepancy relates to …
-
Summary list of field safety notices (FSNs) from medical device manufacturers from 19 April to 23 April 2021
-
Ennogen Pharma Limited are recalling an affected batch of Trimethoprim 200mg Tablets as a precautionary measure due to the observation of a foreign tablet, which is identified as Trimethoprim 100mg Tablet.
-
Diffuplast has identified a potential issue with their third-party sterilisation provider. The risk to patients is very low and therefore patients should continue to use their products as normal.
-
Summary list of field safety notices (FSNs) from medical device manufacturers from 12 April to 16 April 2021
-
Summary list of field safety notices (FSNs) from medical device manufacturers from 05 April to 09 April 2021
-
Users of this continuous glucose monitoring system may experience adverse skin reactions to the sensor.
-
List of field safety notices (FSNs) from medical device manufacturers from 29 March to 02 April 2021.
-
List of field safety notices (FSNs) from medical device manufacturers from 22 March to 26 March 2021.
-
There is the potential for a black residue to be present on all Medoject hypodermic and blunt fill needles
-
List of field safety notices (FSNs) from medical device manufacturers from 15 to 19 March 2021.
-
Macarthys Laboratories Limited T/A Martindale Pharma has informed us that the EAN barcode on the outer carton of a specific batch of Caffeine Citrate 10mg/ml Solution for Injection is incorrect.
-
List of field safety notices (FSNs) from medical device manufacturers from 8 to 12 March 2021
-
Thame Laboratories are recalling the above batches due to an issue with the container closure (child-resistant cap).
-
BD have notified the MHRA that the sterility of some of their devices cannot be guaranteed due to quality issues with their third-party sterilisation provider.
-
Accord-UK Ltd have informed us that important safety warnings for the excipient Propylene glycol are missing from the patient information leaflet (PIL).
-
List of field safety notices (FSNs) from medical device manufacturers from 1 to 5 March 2021
-
The MHRA has made further changes to the way we issue safety messaging to healthcare providers.
-
List of field safety notices (FSNs) from medical device manufacturers from 22 to 26 February 2021
-
Orion Corporation T/A Orion Pharma (UK) Ltd are recalling specific batches as a precautionary measure due to an issue related to moulding defects in the bulk chambers where the inhalation powder is stored.
-
Unknown risks following distribution of product after CE certificate withdrawal
-
List of field safety notices (FSNs) from medical device manufacturers from 15 to 19 February 2021
-
SyriMed are recalling the below batch as a precautionary measure due to an issue related to the container closure (child-lock cap).
-
Eaststone Limited has informed us of an issue related to underfilled or empty bottles for MidaBuc - Midazolam (as HCL) 10mg/mL Oromucosal Solution. The below batch is being recalled.
-
List of field safety notices (FSNs) from medical device manufacturers from 8 to 12 February 2021
-
The MHRA publishes several types of information about medical devices on GOV.UK
-
Gilead Sciences Ltd has informed us of a quality defect issue, in relation to specific lots of 5µm sterile filters, which are co-packed in cartons of the AmBisome product. The medical device is called Minisart Filter 16534-…
-
List of field safety notices (FSNs) from medical device manufacturers from 01 to 05 February 2021
-
Grünenthal Ltd has informed us of a potential microbial contamination during routine stability testing for the batches listed in this recall.
-
Intrapharm Laboratories Ltd has informed us that they have received complaints that the consistency of a batch of Kolanticon Gel 500ml is lumpy. An investigation and retained samples for this batch show the same homogeneity …
-
List of field safety notices (FSNs) from medical device manufacturers from 25 to 29 January 2021
-
List of field safety notices (FSNs) from medical device manufacturers from 18 January to 22 January 2021
-
CSL Behring UK Ltd is recalling specific batches of Respreeza 1,000 mg powder and solvent for solution for infusion (EU/1/15/1006/001) due to a manufacturing deviation that occurred during the filling process.
-
Takeda UK Limited is recalling a batch of Instanyl 100mcg nasal spray solution (EU/1/09/531/015) due to the observation of cracked vials during inspection of the bulk vials and release testing of the finished products.
-
List of field safety notices (FSNs) from medical device manufacturers from 11 January to 15 January 2021
-
List of field safety notices (FSNs) from medical device manufacturers from 04 January to 08 January 2021
-
List of field safety notices (FSNs) from medical device manufacturers from 28 December to 31 December 2020
-
List of field safety notices (FSNs) from medical device manufacturers from 21 December to 24 December 2020
-
Medac Pharma LLP is recalling specific batches of products due to some inspected vials showing hairline damage to the shoulder of the vials. This is a second alert for further batches identified.
-
List of field safety notices (FSNs) from medical device manufacturers from 14 December to 18 December 2020
-
Fresenius Kabi Ltd is recalling the above batch of Sodium chloride 0.9% Solution for injection (PL 08828/0178) which has a polish labelled ampoule within some of the cartons. As this does not impact the full batch, as a prec…
-
Merck Sharp & Dohme Limited is recalling specific batches of Zerbaxa 1g/0.5g Powder for Concentrate for Solution for Infusion as a precautionary measure due to the presence of Ralstonia pickettii in recent batches manufa…
-
Fairmed Healthcare GmbH has informed us of a discrepancy on the product packaging for some batches. The discrepancy relates to the incorrect spelling of one of the active pharmaceutical ingredients printed on one side of the…
-
List of field safety notices (FSNs) from medical device manufacturers from 07 December to 11 December 2020
-
Generics [UK] Limited t/a Mylan have informed us that the Patient Information Leaflet (PIL) within the packs for the products listed above is missing relevant important safety information.
-
List of field safety notices (FSNs) from medical device manufacturers from 30 November to 4 December 2020.
-
Lupin Healthcare (UK) Limited has informed us that the affected batches of Simvastatin tablets have been packaged with a version of patient information leaflet that does not include the most up to date safety information.
-
List of field safety notices (FSNs) from medical device manufacturers from 23 to 27 November 2020.
-
Sanofi is recalling specific batches of Largactil 50mg/2ml Solution for Injection as a precautionary measure due to out of specification results obtained for the impurity chlorpromazine sulphoxide