GovWire

National Patient Safety Alert and Class 4 Medicines Defect Information notice: Prenoxad 1mg/ml Solution for Injection

On 10 November 2022, we issued a National Patient Safety Alert and a Class 4 Medicines Defect Information notice highlighting action needed after being notified of a limited number of Prenoxad packs in a batch marketed in France with missing needles. Naloxone is a drug that reverses the effects of an opioid overdose.

Prenoxad kits are packed with two (2) Terumo 23 gauge 1 inch needles, along with the pre-filled syringe containing the active ingredient (naloxone hydrochloride), and a Patient Information Leaflet. If no needles are present in the kit, there is a risk that patients, members of the public and/or healthcare professionals may not be able to administer life-saving doses of naloxone from these kits in an emergency. This may impede the treatment for a patient with an opioid overdose, which may result in delay to intervention and possible death.

Healthcare professionals and service providers should check all Prenoxad kits against the batches specified in this alert. If they have any of the batches listed, they should carry out the actions set out in the alert before supplying any of the Prenoxad kits. There are no concerns about the medicine in these kits the actions will establish the presence or absence of needles in the packs.

We ask providers to contact individuals supplied with Prenoxad kits, where possible, and support checks to ensure kits contain two (2) needles in each kit. Support should be provided to individuals with kits who are unsure how to check their kits. We have provided a patient letter.

Follow the advice in the National Patient Safety Alert and Class 4 Medicines Defect Information notice.

Letters

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

• Prednisolone 20 mg/dose Rectal Foam: Supply of packs imported from Ireland

• Nulojix risk of medication errors due to change in maintenance dose from 5 mg/kg to 6 mg/kg

• Natpar (parathyroid hormone (rDNA)) 100/75/50/25 micrograms/dose powder and solvent for solution for injection: Discontinuation of manufacturing at the end of 2024 and update on 100mcg shortage

• Supply disruption with Zonegran 25mg/50mg/100mg in the UK (NI)

• Metalyse (tenecteplase): 10,000 units (50 mg) powder and solvent for solution for injection temporary supply shortage

• Ozempic Solution for injection in pre-filled pen (Semaglutide): supply shortage in the UK

• Sialanar 320 mcg/ml oral solution (Glycopyrronium): Interim Supply of Ireland / Germany/ Austria Labelled Stock to Mitigate Supply Disruption

Medicine Recalls and Notifications

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

Class 2 Medicines Recall: Aventis Pharma Limited (t/a Sanofi), Stemetil 5mg/5ml Syrup, EL(22)A/41. Issued on 6 October 2022. Sanofi is recalling all batches of this product as a precautionary measure due to the identification of N-nitrosomethylphenylamine (NMPA) above the acceptable limit. Healthcare professionals should stop supplying the batch immediately, quarantine all remaining stock and return to supplier. However, patients undergoing treatment should be advised not to discontinue Stemetil Syrup without consulting their prescriber. See letter for healthcare professionals issued 10 November 2022.

Class 2 Medicines Recall: hameln pharma ltd, Amiodarone Hydrochloride 50 mg/ml Concentrate for Solution for Injection/Infusion, EL (22)A/42. Issued on 11 October 2022. A recall of batch 210505 of Amiodarone Hydrochloride 50 mg/ml Concentrate for Solution for Injection/Infusion has been initiated as a precautionary measure. This is due to an increased presence of visible crystalline particles within the solution, identified during ongoing re-inspection of retained samples. Healthcare professionals should stop supplying the batch immediately, quarantine all remaining stock and return to supplier.

Class 4 Medicines Defect Information: Flamingo Pharma UK Ltd, Ibuprofen 400mg Tablets, Paracetamol 500mg Tablets (Caplets), EL (22)A/43. Issued on 12 October 2022. An error has been identified relating to the ink printing of the batch number and expiry date on the carton for three batches of Ibuprofen 400mg Tablets. The impacted products are within specification and there is no issue with product quality. Therefore, the affected batches are not being recalled. Healthcare professionals should check the outer carton before dispensing the affected products to ensure the batch number and expiry is present and can be read.

Class 2 Medicines Recall: hameln pharma ltd, Ephedrine Hydrochloride 30 mg/ml Solution for Injection, EL(22)A/44. Issued on 20 October 2022. A recall of affected batches of Ephedrine Hydrochloride 30 mg/ml Solution for Injection has been initiated as a precautionary measure. This is due to out of specification results observed at higher storage temperatures during routine ongoing stability studies for related substances. The results mean the affected batches may no longer be in line with the licensed product specification. Healthcare professionals should stop supplying the batch immediately, quarantine all remaining stock and return to supplier.

Class 4 Medicines Defect Information: Recordati Rare Diseases, Pedea 5 mg/ml solution for injection, EL(22)A/45. Issued on 25 October 2022. Certain batches of Pedea 5 mg/ml solution for injection have been packaged with the incorrect Product Information Leaflet (PIL). The incorrect PIL does not contain important safety information relating to severe skin reactions. In addition, the current Summary of Product Characteristics does not include the relevant safety information. There is no risk to product quality as a

View the original news story