Letters and drug alerts sent to healthcare professionals in December 2020
A summary of letters and drug alerts recently sent to healthcare professionals.
Letters
In December 2020, the following letters were sent or provided to relevant healthcare professionals:
Drug alerts
Class 3 Medicines Recall: Lupin Healthcare (UK) Limited, Simvador 10mg, 20mg and 40mg Tablets, EL (20)A/57. Issued 3 December 2020. Specific batches of simvastatin tablets are being recalled as these have been packaged with a version of the patient information leaflet (PIL) that does not include most up to date safety information. Although there is no risk to product quality, these affected batches are being recalled due to concerns around the omission of the safety information. All remaining stock should be quarantined and returned.
Class 4 Medicines Defect Information: Generics [UK] Limited t/a Mylan, EL(20)A/58. Issued 14 December 2020. Specific batches of perindopril erbumine medicines have been packaged with a version of the patient information leaflet (PIL) that does not include the most up to date safety information. If dispensing, make patients aware of missing information from the PIL provided in their packs.
Class 4 Medicines Defect Information, Co-Careldopa 25mg/100mg tablets, (PL 20242/0028), EL (20)A/59. Issued 15 December 2020. Specific batches contain cartons where the end-flap incorrectly states the active ingredient as ‘carbiopa’ instead of ‘carbidopa’. Healthcare professionals are advised to exercise caution when dispensing the product.
Class 2 Medicines Recall: Merck Sharp & Dohme Limited, Zerbaxa 1g/0.5g Powder for Concentrate for Solution for Infusion, EL (20)A/60. Issued 16 December 2020. Batches of this Zerbaxa (ceftolozane sulfate / tazobactam sodium) are being recalled as a precautionary measure due to retained batches showing presence of Ralstonia pickettii. Stop supplying the batch immediately and return to supplier. Patients are advised to speak to their doctor or pharmacist if they experience any worsening of symptoms or other side-effects.
Company led drug alert: Sodium chloride 0.9% Solution for injection (PL 08828/0178), EL (20)A/04. Issued 18 December 2020. A specific batch of sodium chloride is being recalled due to Polish-labelled ampoules within some of the cartons. Although there is no risk to product quality, as a precautionary measure packs with the listed batch number should be returned.
Class 2 Medicines Recall, medac GmbH (T/A medac Pharma LLP) Sodiofolin 50mg/ml Solution for Injection 100mg/2ml, PL 11587/0005, EL (20) A/61. Issued 29 December 2020. Specific batches of Sodiofolin are being recalled due to some inspected vials showing hairline damage to the shoulder of the vials. This is a second alert for further batches identified.
Article citation: Drug Safety Update volume 14, issue 6: January 2021: 7.