Starting January 1st  2021 as a cannabis product manufacturer, you will have to be prepared for new MED (Marijuana Enforcement Division) recall guidelines. This will include having a written recall plan in place. We want to help you prepare for these changes, so we’ve put together some resources and distilled what you need to know. 

First off, know that you can voluntarily undertake a recall at any time or at the request of MED. Why volunteer for such a task? 

  • To protect consumers from harmful products & legal liability
  • To mitigate brand damage by proactively taking action 

Recall Plan

  1. Evaluation of the product problem
  2. Identifying compromised products
  3. Notifying affected parties
  4. Removal of compromised products
  5. Disposal & decontamination of products
  6. Ensuring recall was effective
  7. Ending the recall

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    1. Evaluation of the product problem
      1. Customers might reach out with quality concerns or complaints about adverse reactions to your products. You will be required to maintain a record of all complaints received. We recommend keeping these complaints stored in the notes section on the relevant batch page in Batchbud (or wherever you store your digital records). This will help you easily search & locate notes as well as mark the batch you may need to recall once you’ve investigated the complaint.
      2. When you receive a complaint you must use “reasonable diligence” to look into the problem to figure out the issue.
      3. If your assessment of the complaint investigation indicates a recall is necessary, you need to:
        1. Determine the hazard & evaluate safety concerns.  
        2. Assure product quarantine steps have been taken (if product is still in your possession)
        3. Decide on a product removal strategy appropriate for the threat & location in commerce. 
        4. Lastly you should report directly to CDPHE & MED, and notify your local licensing authority or local jurisdiction where the product is made (see “3. Notifying affected parties” for templates). 
    2. Identifying compromised products
      1. In this step you’ll need to generate a distribution list. If you use Batchbud’s Leaflink integration we can automatically generate these lists for you.
      2. The product information.
      3. Lastly, to the extent that you can reasonably gather the following information your plan should include the amounts of compromised product. 
    3. Notifying affected parties
      1. When you initiate the recall you will need to notify the receiving licensee(s) about the issue with the products they purchased.
      2. As noted above, you will also need to send notice to CDPHE, MED and your local licensing authority or local jurisdiction.
      3. Lastly you have to send consumers a notice by the most effective method available. A press release works well, so we’ve included a sample of different types of recall press releases, based on FDA examples.
    4. Removal of compromised products 
      1. This part of your recall plan defines how you will detain, segregate & handle compromised products in commerce.
      2. Products that are still under your control should be detained & segregated.
      3. When products are returned, you should clearly label them with “not for sale or distribution” and clearly separate them from any other products.
    5. Disposal & decontamination of products 
      1. Destroy and document the destruction of the Products Inventory Tracking System package or Production Batch pursuant to Rule 3-235 (Transfers of Fibrous Waste Page 83-85) or;
      2. Decontaminate the affected Inventory Tracking System package or Production Batch pursuant to Rule 4-135(B)(2) (Page 173).
    6. Ensuring recall was effective
      1. You will be responsible for checking if your recall has been effective. If less than 100% of the recalled product has been accounted for, you will need to do an effectiveness check. Batchbud automates this process, but if you don’t currently use Batchbud we included an email template to help verify:  
        1. If the receiving Licensee received the recall notification;
        2. If the recalled Product was handled as instructed in the recall notification; and
        3. If the Product was further distributed or sold by the receiving Licensee before receipt of the recall notification, and if so, were these additional Licensees notified.   
    7. Ending the recall   
      1. If MED requested the recall they will determine termination of recall by issuing written nontification.
      2. If licensee initiated they will determine. Either way the following must be met: 
        1. All reasonable efforts have been made to remove or correct the Product in accordance with the recall plan, and 
        2. When it is reasonable to assume that the Product subject to the recall has been removed and proper disposition or correction has been made commensurate with the degree of hazard of the recalled Product.
      3. A recalling MIP may request termination of its recall by submitting a written request to the Division stating that the recall is effective in accordance with this Rule, and by accompanying the request with a recall status report and a description of the disposition of the recalled Medical Marijuana Concentrate or Medical Marijuana Product.

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