Letters and medicine recalls sent to healthcare professionals in December 2021
A summary of recent letters, medicine recalls and notifications sent to healthcare professionals.
Letters
In December 2021, the following letters were sent or provided to relevant healthcare professionals:
Medicine Recalls and Notifications
In December 2021, recalls and notifications for medicines were issued on:
Class 2 Medicines Recall: Intrapharm Laboratories Ltd, Mydrilate 0.5% Eye Drops 5ml, EL (21)A/35. Issued 8 December 2021 A batch of Mydrilate (cyclopentolate hydrochloride) 0.5% Eye Drops 5ml is being recalled as a precautionary measure due to out of specification results identified during stability testing. Stop supplying the batch immediately, quarantine all remaining stock and return to supplier.
Class 2 Medicines Recall: Novartis Pharmaceuticals UK, Lucentis 10 mg/ml solution for injection in pre-filled syringe EL (21)A/36. Issued 13 December 2021. A batch of Lucentis (ranibizumab) 10 mg/ml solution for injection in pre-filled syringe 5ml is being recalled due to a defective plunger stopper. The Marketing Authorisation Holder has received increased numbers of customer complaints that the plunger in this batch is difficult to press down. Stop supplying the batch immediately, quarantine all remaining stock and return to supplier.
Class 4 Medicines Defect Information: SmofKabiven Central emulsion for Infusion, Fresenius Kabi Ltd, EL (21)A/37. Issued 16 December 2021. Batches of SmofKabiven central emulsion for Infusion have been identified that incorrectly state the amount of glucose anhydrous in the energy content section as 150mg. The correct value of 125mg glucose anhydrous (42% glucose as monohydrate) is stated in the rest of the product information, including the Summary of Product Characteristics, outer carton and on the infusion bag ingredients. Healthcare professionals are advised to exercise caution when administering this product particularly when calculating patient nutritional requirements.
Class 2 Medicines Recall: Wockhardt UK Ltd, Heparin sodium 1,000 I.U./ml solution for injection or concentrate for solution for infusion, EL (21)A/38. Issued 20 December 2021. A batch of heparin sodium 1,000 I.U./ml solution for injection or concentrate for solution for infusion is being recalled as a precautionary measure due to out of specification results identified during stability testing. Stop supplying the batch immediately, quarantine all remaining stock and return to supplier.
Class 4 Medicines defect information: Benylin Chesty Coughs Original (P) and Benylin Chesty Coughs Non-Drowsy (GSL), EL(21)A/39. Issued 21 December 2021. Batches of Benylin chesty coughs original (diphenhydramine hydrochloride and levomenthol) and Benylin chesty coughs non-drowsy (guaifenesin and levomenthol) have been identified with incorrect product information. The product labelling in affected batches states an incorrect alcohol content of 0.25mg or 0.7mg in each 5ml, where the correct alcohol content for both products is 198mg per 5ml. The safety advice on the label regarding the amount of alcohol contained in these products is low and will not have any noticeable effects is correct.
Company led medicines recall: Dermaved Sensitive Cream (unlicensed medicine), CLMR (21)A/09. Issued 30 December 2021. A batch of Dermaved sensitive Cream is being recalled. This product is supplied by Dermaved online only. This is an unlicensed skin medication, and the affected batch has been identified to contain low levels of clobetasol propionate, a strong steroid which is only available as a prescription treatment for skin conditions.
Medical Device Safety Information
A recent MHRA Device Safety Information page has been published on:
For all of the latest safety notices from the MHRA on drugs and medical devices, see Alerts and recalls for drugs and medical devices.
Article citation: Drug Safety Update volume 15, issue 6: January 2022: 4.