Company led medicines recall: Spectrum Therapeutics UK, Canopy AKH 22 Dried Cannabis 5g [unlicensed medicine], CLMR (23)A/04

The importer and distributor of the above products has informed us of reports that the microbial limit for Total Microbial Aerobic Count (TAMC) has been tested to exceed the predefined limit of 200 CfU/g as per the product specification fixed according to Pharm. Eur. Monograph 5.1.4 (inhalation use).

CLMR Number: CLMR (23)A/04

MDR Number: MDR 085-04/23

Company name: Spectrum Therapeutics UK

Product description: Canopy AKH 22 Dried Cannabis 5g [unlicensed medicine]

Details of the affected batch:

Brief description of problem:

The importer and distributor of the above products has informed us of reports that the microbial limit for Total Microbial Aerobic Count (TAMC) has been tested to exceed the predefined limit of 200 CfU/g as per the product specification fixed according to Pharm. Eur. Monograph 5.1.4 (inhalation use).

Therefore, these batches are being recalled as a precautionary measure. This recall is being issued as a company-led recall due to the limited number of packs distributed and the related level of risk. Spectrum Therapeutics UK is able to fully trace the onward distribution by their customers.

Advice to Healthcare Professionals and wholesalers:

• Stop supplying the batches above immediately. Quarantine all remaining stock and liaise with Spectrum Therapeutics UK on the return process.
• Spectrum Therapeutics UK has full traceability and will contact pharmacy teams that have dispensed the affected products.
• Healthcare professionals should contact patients who have received the affected packs to arrange the return of any unused product.

Advice to Patients:

• Spectrum Therapeutics UK is recalling the above product as a precautionary measure. They have currently received no reports of any adverse events due to the out of specification observed.
• Healthcare professionals will contact patients who may have been dispensed the impacted batches of this product directly.
• Patients should contact their pharmacist or doctor for advice if they have received stock from the affected batches and have not been contacted. Where available, Spectrum Therapeutics UK is making arrangements to supply patients with unaffected batches.
• Any suspected defect of the medicine and/or side effects should be reported via the Yellow Card scheme.

Company contacts for further information:

Medical Information : stefanie.dinner@canopygrowth.com

Stock Enquiries : info@spectrumtherapeutics.com