The Ontario Cannabis Store (OCS) has posted a recall for a cannabis product they say is an unapproved prescription drug.
In a notice posted online on April 18, the OCS says that the product “Goodnight Dream Caps” from Taima Extracts Inc. is being recalled due to a “risk calculation associated with this product” as a Type II recall.
A Type II (2) recall refers to a product that can cause temporary adverse health consequences or where the probability of serious adverse health consequences is remote.
There are generally three types of product recall designations in Canada, Type (or class) I, II, and III, with Type I representing the highest risk and Type III representing the lowest risk to public health.
Most recalls for cannabis products in Canada have been Type III recalls, generally related to inaccurate labelling.
This notice affects all lots and packaging dates of the product that was sold in Ontario.
On April 20, Health Canada also issued their own recall notice for the product, stating it was an unauthorized product sold without market authorization (DIN) in Canada.
Although the product has now been removed, the soft gels were previously listed on the OCS website as each containing 20 mg of CBD, zero THC, as well as 10 mg of melatonin, and chamomile oil.
The previous product listing on the OCS noted the producer was Voyage Cannabis, while the recall notice attributes the product to Taima. Voyage Cannabis was acquired by Heritage cannabis in 2022. The recall notice is not associated with Heritage Cannabis or Voyage Cannabis.
The OCS notice does not make it clear what caused the product to be considered an unapproved prescription drug.
Health Canada regulates melatonin under the Natural Health Products Regulations. It’s commonly advertised as an effective sleep aid; however, some medical experts warn that it can cause side effects such as dizziness, nausea, headaches, and muscle aches if used in high doses.
Health Canada recently issued a product recall for a CBD product on April 4 that contained 20mg of CBD and 3mg of Melatonin, calling it an “unauthorized product.” The notice said it was a product sold without market authorization (DIN) in Canada. A DIN is a Drug Identification Number.
Taima and the OCS were not immediately available for comment.
Any new cannabis product that enters the market must first provide Health Canada with a Notice of New Cannabis Product (NNCP) at least 60 calendar days before making the new cannabis product available for sale.
This article will be updated as new information becomes available.
This article has been updated to note Health Canada issued a recall notice for the Goodnight Dream Caps in April 20.