Company led medicines recall: Spectrum 皇冠体育apprapeutics UK, Canopy AKH 22 Dried Cannabis 5g [unlicensed medicine], CLMR (23)A/04
皇冠体育app 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 皇冠体育apprapeutics UK
Product name
Canopy AKH 22 Dried Cannabis 5g [unlicensed medicine]
Lot number/expiry
| Product name | Batch number | Expiry date | Pack size | Date first distributed |
|---|---|---|---|---|
| Canopy AKH 22 Dried Cannabis [unlicensed medicine] | R4N1217CA-5R2-6 | 30/04/2023 | 5g | 09/01/2023 |
| Canopy AKH 22 Dried Cannabis [unlicensed medicine] | R4N1217CA-5R3-6 | 30/06/2023 | 5g | 02/03/2023 |
Brief description of problem
皇冠体育app 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).
皇冠体育apprefore, 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 皇冠体育apprapeutics UK is able to fully trace the onward distribution by their customers.
Advice for healthcare professionals and wholesalers
- Stop supplying the batches above immediately. Quarantine all remaining stock and liaise with Spectrum 皇冠体育apprapeutics UK on the return process.
- Spectrum 皇冠体育apprapeutics 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 for patients
- Spectrum 皇冠体育apprapeutics UK is recalling the above product as a precautionary measure. 皇冠体育appy 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 皇冠体育apprapeutics 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.