GovWire

Letters

In June 2022, the following letters were sent or provided to relevant healthcare professionals:

• Dexmedetomidine: clinical trial finds increased risk of mortality in intensive care unit (ICU) patients aged 65 years or younger
• Defitelio (defibrotide): Do not use for prophylaxis of venoocclusive disease (VOD) after post-hematopoietic stem-cell transplantation (HSCT)
• Imlygic (talimogene laherparepvec) - important information: special considerations to minimise the potential occurrence of adverse events in HSV-1 seronegative patients receiving vials from affected lots
• Calcium Folinate 10 mg/ml solution for injection or infusion: supply of the Irish product

Medicine Recalls and Notifications

In June 2022, recalls and notifications for medicines were issued on:

Class 4 Medicines Defect Information: OxyContin 20 mg prolonged release tablets, EL (22)A/27. Issued 1 June 2022. Batches of OxyContin (oxycodone hydrochloride) 20mg prolonged release tablets have been identified to have Braille on the cartons that incorrectly states the strength as 15mg. Healthcare professionals should confirm when dispensing this product if this medicine is being collected on behalf of somebody who will solely rely on Braille, and if so, explain the error in the Braille.

Class 2 Medicines Recall: Bristol Laboratories Limited, Phenobarbital 60 mg Tablets, EL(22)A/28. Issued 13 June 2022. A batch of Phenobarbital 60mg tablets is being recalled as a precaution due to low dissolution test results reported during stability studies. Stop supplying the batch immediately, quarantine all remaining stock and return to supplier.

Company led medicines recall: PCCA Limited, Ketamine 50mg in 5ml Oral Solution and Ketamine 100mg in 5ml Oral Solution (unlicensed medicines), CLMR (22)A/04. Issued 15 June 2022. Batches of unlicensed ketamine 50mg in 5ml oral solution and 100mg in 5ml oral solution are being recalled due to the appearance inside the vials of a crystalline material. Healthcare professionals who have dispensed this product, should contact patients directly to return any impacted products. Stop supplying the batch immediately, quarantine all remaining stock and return to the company.

Class 4 Medicines Defect Information: Altan Pharma Limited, Phenylephrine 0.08 mg/ml - solution for injection/infusion, EL(22)A/29. Issued 16 June 2022. A batch of phenylephrine (phenylephrine hydrochloride) 0.08 mg/ml solution for injection or infusion has been identified that states incorrect concentration of the phenylephrine base on the overwrapping bag label. The incorrect label states that each bag of 100ml contains 10mg of phenylephrine base, as opposed to the correct 8mg of phenylephrine base. Healthcare professionals are advised to exercise caution when using the product should refer to the label dose on the actual bag, which remains correct for this batch.

Company led medicines recall: A.Vogel Ltd, Linoforce granules 12 years plus (THR 13668/0021), CLMR (22)A/05. Issued 22 June 2022. A batch of Linoforce granules 12 years plus (whole linseed; senna leaf; frangula bark) is being recalled as a small number of packs of these pharmacy-only medicines were supplied to non-pharmacy outlets. Remaining stock of the above batch should be quarantined and returned to the company directly.

For all of the latest safety notices from the MHRA on drugs and medical devices, see Alerts and recalls for drugs and medical devices.

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Article citation: Drug Safety Update volume 15, issue 12: July 2022: 3.