Letters and drug alerts sent to healthcare professionals in August 2020

A summary of letters and drug alerts recently sent to healthcare professionals.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 23 September 2020

• Therapeutic area: Cardiovascular disease and lipidology, Haematology, Paediatrics and neonatology, Rheumatology and Urology and nephrology

Letters

In August 2020, the following letters were sent or provided to relevant healthcare professionals:

• RoActemra (tocilizumab) 162 mg Solution for Injection in Pre-filled Syringe: Interim supply of Irish livery stock to mitigate supply disruption

• Fresenius Propoven 2% Emulsion for Injection or Infusion (propofol): Interim Supply of European Stock to Mitigate Supply Disruption

• Wockhardt UK’s Amoxicillin Sodium 250mg, 500mg and 1g powder for solution for injection: caution and monitoring requirements

So far in September 2020, the following has been provided to healthcare professionals to support the supply of medicines:

• Ativan 4mg/ml Solution for Injection (Lorazepam): Temporary supply of a different presentation and changes to the instructions (updated)

Drug alerts

Class 2 Medicines Recall: Pharmaram Ltd, Clexane 4,000 IU (40mg)/0.4ml Syringes, EL (20)A/37. Issued 4 August 2020. A specific batch of Clexane 4,000IU (40mg)/0.4ml syringes has an error on the labelling affixed to the plastic blister packaging encasing the syringe (the label incorrectly states ‘Clexane 6,000IU (60mg)/0.6ml Syringes’). Stop supplying the products immediately and return to supplier. Inform patients who have been supplied this batch that the error is only with the labelling on the plastic blister packaging encasing the syringe.

Class 2 Medicines Recall: Huddersfield Pharmacy Specials MS 19055, Phosphates Solution for Infusion 500ml, EL (20)A/38. Issued 10 August 2020. The listed batches of phosphates solution for infusion have been recalled due to observation of precipitation in one batch. Stop supplying the products immediately and return to supplier.

Class 2 Medicines Recall: Sanofi Fasturtec 7.5 mg, 1.5 mg/ml powder and solvent for concentrate for solution for infusion, EL (20)A/40. Issued 24 August 2020. Batch number A9306 has been recalled as a precautionary measure due to an out of specification result. Stop supplying the products immediately and return to supplier.

Class 3 Medicines Recall: Accord-UK Ltd, Digoxin Tablets BP 250 micrograms, EL (20)A/35. Issued 3 August 2020. There is an issue related to decommissioning of a specific batch. Although there is no risk to product quality, any remaining stock should be quarantined and returned.

Class 4 Medicines Defect Information: Crescent Pharma Ltd, SyreniRing 0.120 mg/0.015 mg per 24 hours, vaginal delivery system, EL (20)A/36. Issued 3 August 2020. The Patient Information Leaflet (PIL) within the packs for the listed batches are missing important safety relevant text changes. If dispensing any of the listed batches, ensure patients are aware of any missing information.

Class 4 Medicines Defect Information: SmofKabiven extra Nitrogen Electrolyte Free, EL (20)A/39, PL 08828/0269. Issued 13 August 2020. There is an error on the bag labels for SmofKabiven extra nitrogen electrolyte free emulsion for infusion. Healthcare professionals should be aware that there is a product available with electrolytes and caution should be exercised when dispensing and administering this product.

Article citation: Drug Safety Update volume 14, issue 2: September 2020: 5.

Published 23 September 2020