Healthcare professionals and members of the public should continue to follow Government advice on novel coronavirus and coronavirus disease (COVID-19). For information about how MHRA is contributing to the essential work needed to protect public health in the UK, see MHRA statement.
Letters from February 2020
Recall of Emerade 150 microgram adrenaline pens
Class 2 Medicines Recall: Emerade 150 micrograms solution for injection in pre-filled syringe, PL 33616/0013 (EL(20)A/14). 4 March 2020.
On 4 March 2020, all unexpired batches of Emerade 150 microgram auto-injectors (pens) were recalled from patients due to an error in one component believed to cause some pens to fail to activate and deliver adrenaline. See the Drug alert for all advice.
Healthcare professionals – doctors, nurses and pharmacists – should ensure patients and carers receive training in correct use of any new adrenaline pen supplied.
Class 2 Medicines recall: Accord-UK Ltd, Gliclazide 40mg Tablets (Northstar Livery), PL 20075/0687, (EL (20)A/08). Issued 13 February 2020. All unexpired stock of Gliclazide 40mg Tablets (Northstar Livery) is being recalled from pharmacies and wholesalers as a precautionary measure due to out of specification results for dissolution obtained during routine stability testing.
Class 2 Medicines recall: Medreich PLC, Ranitidine 150mg Tablets, PL 21880/0091, Ranitidine 300mg Tablets, PL 21880/0092 (EL (20)A/05). Issued 3 February 2020. All unexpired stock of the ranitidine 150mg and 300mg tablets is being recalled from pharmacies and wholesalers as a precautionary measure due to possible contamination with an impurity N-nitrosodimethylamine (NDMA), which has genotoxic and carcinogenic potential.
Company led drug alert – Iohexol solution for injection (350mg/ml and 300mgI/ml). Issued 6 February 2020. Specific batches are being recalled from wholesalers and pharmacies as a precautionary measure due to an out of specification result in the ongoing stability studies.
Class 3 FMD Medicines Recall, Beconase Aqueous Nasal Spray, (Beclometasone Dipropionate 50μg), PL 10949/0104, EL (20)A/07. Issued 12 February 2020. There is an issue related to error in the decommissioning of the K84X batch. Although there is no risk to product quality, any remaining stock should be quarantined and returned.
Class 4 Medicines Defect Information: Oxylan prolonged-release tablets, all strengths (oxycodone hydrochloride), (EL (20)/A12). Issued 27 February 2020. The Patient Information Leaflet (PIL) within the packs for the specified batches is missing important safety-relevant text changes about warnings, interactions, and possible side effects. Check product and batch and, if dispensing, ensure that patients are aware of any missing information. The updated PIL is available online.
Class 4 Medicines Defect Information: Memantine 10mg Film-Coated Tablets, PL 20416/0260, (EL (20)A/11). Issued 25 February 2020. There is a discrepancy with the product packaging for the listed patched. One side of the pack (end flap) notes an incorrect number of tablets. There is no risk to product quality as a result of this issue and the associated batches are not being recalled at this time; however, exercise caution when dispensing the product.
Class 4 Drug Alert: Crescent Pharma Ltd and Flamingo Pharma (UK) Ltd, Ibuprofen 400mg Tablets, (EL (20)A/10). Issued 20 February 2020, updated 24 February 2020. The Patient Information Leaflet within listed batches of pharmacy (P) products contains incorrect dosing instructions. If dispensing these batches, ensure that patients are aware of the correct dosage instructions and follow the maximum daily dose stated on the carton labelling (3 tablets a day [1200mg]).
Class 4 FMD Medicines Defect Information: Diamorphine Hydrochloride BP 100mg Lyophilisate for Solution for Injection, PL 20075/0675, (EL (20)A/09). Issued 17 February 2020. The expiry date for the listed batches has not been encoded in 2D data matrix. Attempts to scan the FMD 2D Data Matrix code on the pack will result in an ‘Alert’ or a failed scan. Perform the usual checks for falsified medicines according to the FMD Source guidance and dispense if deemed acceptable based on these checks.
Class 4 Medicines Defect Information: Atrolak XL Prolonged-release tablets, all strengths (quetiapine fumarate). The Patient Information Leaflet (PIL) for all strengths of this product is missing information about possible side effects – Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). If dispensing these batches, ensure that patients are aware of any missing information.
Article citation: Drug Safety Update volume 13, issue 8: March 2020: 6.