Letters and medicine recalls sent to healthcare professionals in March 2021

A summary of letters and recent medicine recalls and notifications sent to healthcare professionals.

Letters

In March 2021, the following letters were sent or provided to relevant healthcare professionals:

We are also aware of the following letter, sent to relevant healthcare professionals in February 2021:

Medicines Recalls and Notifications

Class 3 Medicines Recall: Easyhaler Salbutamol Sulfate 100 micrograms per actuation/200 micrograms per actuation inhalation powder, EL (21)A/06. Issued 1 March 2021. Defects have been identified in two batches of Easyhaler Salbutamol Sulfate 100 micrograms and 200 micrograms per actuation inhalation powder. A hole in the bulk chamber where inhalation powder is stored has potential for a minor loss of inhalation powder. As a precautionary measure, the product is being recalled. Stop supplying the batch immediately, quarantine all remaining stock and return to supplier.

Class 4 Medicines Defect Information, Accord Diazepam 2mg/5ml Oral Solution Sugar Free (EL (21)A/07) (PL 0142/0103). Issued 9 March 2021. Batches of Accord’s Diazepam 2mg/5ml oral solution have been identified with incomplete product information. The products have outdated sorbitol wording and are missing important excipient safety wording on propylene glycol. Accord will provide hard copies of updated leaflets to pharmacies. When prescribing, healthcare professionals are asked to inform patients and provide updated product leaflets from the supplier when dispensing the product.

Class 3 Medicines Recall: Thame Laboratories, Itraconazole 10mg/ml Oral Solution, EL (21)A/08. Issued 15 March 2021. Two batches of Itraconazole 10mg/ml oral solution are being recalled due to defective child-resistant container closures which are difficult to open. Stop supplying the batch immediately, quarantine all remaining stock and return to supplier.

Class 4 Medicines Defect Information, Caffeine Citrate 10mg/ml Solution for Injection, (PL 01883/0344), EL (21)A/09. Issued 18 March 2021. A batch of Caffeine Citrate 10mg/ml Solution for Injection has been identified with an incorrect EAN barcode on the outer carton. Scanning the barcode will show the batch as Methylthionium Chloride Injection 1%. There is no risk to product quality, and all other packaging components are correct. Healthcare professionals are advised not to use barcode scanning for any activities related to this batch and to use caution when supplying or dispensing this item, as the barcode may show incorrectly on automated pharmacy inventory systems.

Article citation: Drug Safety Update volume 14, issue 9: April 2021: 3.

Published 27 April 2021