Two batches of medical cannabis products have been recalled by regulators as investigations are carried out, following reports they may be contaminated with mould.
Medical cannabis pharmacy, Dispensary Green and the Medicines and Healthcare products Regulatory Agency (MHRA) have issued a ‘precautionary’ product recall since being made aware of ‘defects’ in patient’s medication.
Concerns were initially raised after a number of medical cannabis patients spotted what they believed to be mould spores in their prescriptions.
Last week Dispensary Green released a statement confirming that ‘inconsistencies’ were found in two batches of NOIDECS indica and sativa flower.
The batches, identified as NOIDECS T20:C4 Sativa – 14NS2021002 and NOIDECS T20:C4 Indica – 14NI2021002 are said to have been placed in quarantine while investigations are carried out by the MHRA and manufacturer, Bol Pharma.
The pharmacy is requesting that all patients discontinue their use of these products and processes have been put in place for both opened and unopened packs to be returned.
One patient, speaking to Cannabis Health anonymously, believes she has been unknowingly inhaling mould for at least a month.
“I noticed a slight wheeze on my chest, which I thought was hayfever. After I got my jeweler’s loupe out and checked my batch under a microscope, you can see it has a little bit of mould on it,” she says.
“I have vaped most of it as I wasn’t aware it was happening and over the last month my pain has been massively improving. I have an autoimmune disease so you might expect to be really ill from inhaling mould, but I haven’t really had any adverse effects.”
Another patient, who had never used cannabis before being prescribed, said they felt they were “naive” to trust that the medication would be completely safe.
“As a patient who never used cannabis previously, I feel like I was a bit naive to think that a pharmaceutical grade botanical product would never have a bad batch and that I could just fully trust the medication. But there are recalls in numerous countries for similar problems so it can and does happen, and you just need to be prepared,” they said.
They told Cannabis Health they would now be purchasing a USB microscope to check their medication after it arrives, and before use to ensure it hasn’t become mouldy in storage.
The patient added: “I trust that the producers will be implementing additional QC procedures after they determine where in the supply chain this occurred, and hopefully this will lead to better quality in general for all UK medical patients.“
Patient advocacy group Patient-Led Engagement for Access (PLEA) said substandard quality, such as mould in any medicinal product was “unacceptable”.
“Quality and consistency is vital to medicinal cannabis treatment, with Good Manufacturing Practice (GMP) standards providing assurance that medication is produced to a pharmaceutical grade,” the PLEA management committee said in a statement.
“Substandard quality, such as mould, is unacceptable in a medicinal product. As a plant-based medicine, variation and degradation can occur during the manufacturing and importation process. As with all manufactured foods and medicines, a recall process exists and ensures that any faulty products will be pulled from use.”
The organisation called for more transparency from producers and for a “robust” UK supply chain to ensure more control over processes.
“Trust in the system is important, and at present the MHRA regulates how producers meet GMP standards and this information is not shared with patients,” they added.
“Patients would like to see more transparency from licensed producers, providing a certificate of analysis for each batch that confirms it is free from contamination at the point of testing and cannabinoid and terpene profiling.
“In future, having a robust supply chain within the UK will allow more control over farm to patient processes as well as employment and investment opportunities. PLEA will continue to work with the industry to ensure standards are patient-centred and that concerns are heard.”
Dispensary Green, which is run by Lyphe Group, told Cannabis Health that the welfare of patients is its “priority”, with staff working “around the clock” to contact anyone who has received these medications and provide the appropriate support.
The company said in a statement: “Since we were made aware of a few patients spotting possible defects in medication from two batches of NOIDECS T20:C4, we have been working closely with our warehouse partner and MHRA to put a precautionary product recall (patients can choose whether they would like to return affected product) into place swiftly.
“The manufacturer, Bol Pharma, and the MHRA continue to investigate these two batches and we expect to hear the results in the coming weeks.
“Our team at Dispensary Green pharmacy are working around the clock to call all patients that have received medicine from these two batches and can provide support as needed.
“We are requesting that all patients discontinue use if they have medicine from these two batches, and return all packs in their possession. This includes unopened packs and opened packs.
“There is minimal risk for any patients that have taken the affected medical cannabis products, highlighted by the ‘precautionary’ recall from the MHRA. Our priority at Dispensary Green has always been the welfare of our patients and we shall continue to act transparently and closely with patients to resolve this matter.”
It also warned that some activists were using the incident as an opportunity to “push an agenda” which promotes illicit cannabis use.
“It is deeply concerning that some grow-your-own activists are using this event as an opportunity to degrade the hard-work of the medical cannabis community and push an agenda focused on the illegal consumption of product sourced from clandestine black market cannabis growers. The legal medical market is priced competitively and built to safeguard patients so we can rid the country of black market dealers,” the statement continued.
“As always, it’s important to ensure that medical cannabis is stored correctly by patients. For natural flower products the direction is for pouches not to be opened until consumed, and then kept in the sealed pouch and stored away from light at room temperature.
The manufacturer, Bol Pharma, which is based in Israel, commented: “The issue in subject is under thorough investigation by us, throughout all required quality assurance and processes.
“Being one of the country’s leading medical cannabis companies, BOL Pharma is committed to its patients and to provide the highest manufacturing standards under the strictest regulatory and manufacturing environments, hence following the strictest protocols, particularly when patients and quality complaints are involved.
“Samples from the batches in discussion are being examined. A process that normally takes up-to 10 working days. The results and conclusions are then submitted to our importer and distributors in the UK.”
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