Letters and drug alerts sent to healthcare professionals in November 2020

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

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Letters

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

Drug alerts

Class 4 Medicines Defect Information, Kolanticon Gel 200ml, (PL 17509/0084), EL (20) A/51. Issued 9 November 2020. For one batch of this product, there is a difference in dosage instructions between the carton and label – the Patient Information Leaflet (PIL) and bottle label contain the correct instructions. When dispensing or providing this product, please check batch number and ensure that patients are aware of the correct dosing instructions.

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/52. Issued 11 November 2020. A specific batch is being recalled as a precautionary measure due to some inspected vials showing hairline damage to the shoulder of the vials. Stop supplying the batch immediately and return to supplier.

Class 2 Medicines Recall, Mylan UK Healthcare Ltd, Ancotil 2.5 g/250 ml Solution for Infusion, PL 46302/0116, EL (20) A/53. Issued 12 November 2020. Remaining stock of certain batches is being recalled as a precautionary measure after a product sterility non-compliance during a recent inspection at the contract manufacturing site. Stop supplying the batches immediately and return to supplier.

Class 2 Medicines Recall: Kyowa Kirin Limited, Abstral 200 microgram sublingual tablets, EL (20)A/54. Issued 25 November 2020. Specific batches are being recalled as a precautionary measure due to reports of double tablets in a single-blister pocket. Stop supplying the batches immediately and return to supplier.

Class 2 Medicines Recall: Kent Pharmaceuticals Ltd, Betahistine dihydrochloride 8mg and 16mg Tablets, EL (20)A/55. Issued 26 November 2020. Affected batches are being recalled following contamination with theophylline due to a cross-contamination issue identified with an excipient used in the manufacture of the finished product. Stop supplying the batches immediately and return to supplier.

Class 2 Medicines Recall: Aventis Pharma Limited (t/a Sanofi), Largactil 50mg/2ml Solution for Injection, EL (20)A/56. Issued 26 November 2020. Specific batches of Largactil 50mg/2ml Solution for Injection are being recalled as a precautionary measure due to out of specification results obtained for the impurity chlorpromazine sulphoxide. Stop supplying immediately and return to supplier.

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Article citation: Drug Safety Update volume 14, issue 5: December 2020: 4.

Updates to this page

Published 17 December 2020