This post is further information for the 67 patients from my clinic who are affected by this recall. I notified you all just before Christmas. You will be asked by text or phone call on Monday 04 Jan 2016 to read this post. Those not affected by the recall can continue to use the product.
The problem
The problem arose from a new IT system established at Stallergenes in the production centre in France. This resulted in “operational disruptions and some incorrect product deliveries”. The French Health Authority suspended all production and distribution of Stallergenes products in France on 2 December 2015 link to Press Release here (technically the world company is now called Stallergenes-Greer and the subsidiary company in France is Stallergenes SAS. The Australian subsidiary is Stallergenes Australia Pty Ltd. I will refer to the company as Stallergenes).
Subsequently Stallergenes in Australia was directed by the Therapeutic Goods Administration (TGA) in Australia to recall certain products from 17 Dec 2015. Allergists in Australia received this notice from Stallergenes in Australia by email which was received by me at 12.44pm on 21 Dec 2015. Stallergenes wrote in the email that the email was a followup of a letter they sent to all allergists in Australia on 17 Dec 2015 but which I only received on 23 Dec 2015, two days after the email.
The email listed 67 of my patients affected by the recall. By the following day I had notified all these patients by text message (by phone in two cases) to stop the sublingual immunotherapy (allergy drops) and await instructions in the first week of the New Year.
What to do
- Ring Stallergenes Australia on 1 800 635 306 or 1800 824 166
- Advise them that you are a patient of Dr John Weiner and he advised that your treatment is subject to a recall and that you would like a full refund of the recalled product.
- Please remember that the person on the other end of the line is a staff member in Sydney who is not responsible for this recall and who is just doing his/her job.
- If asked whether you have returned the drops to your doctor or to me, just say that Dr Weiner advised you to return them to his clinic which you will do in due course (more on this later). Some of you have the recalled drops still in my clinic.
- I expect that you will be granted a full refund of the recalled product. Please record the staff member’s name or employee number.
- If there are any problems obtaining promise of a refund, ask if you could escalate your enquiry. If that doesn’t work, please email Sebastien Nicolas on snicolas@stallergenes.com.au . He is the 2nd in charge of Stallergenes Australia and I am dealing with him on this issue. I have asked him to arrange full refunds immediately, whether the recalled product has been returned or not.
- Once your refund is confirmed, email my clinic on allergynetaustralia@gmail.com with your name and date of birth. You have 3 choices. You can advise that you would like to stop the program. Or you could request a resupply from another manufacturer which I will arrange immediately. Or you could ask me what to do and I will get back to you in due course.
- If you request a new supply from a different manufacturer, I will order a product called Oraltek from Inmunotek (company link here) in Spain through their Australian agent. Their delivery time is 4-6 weeks. Cost is slightly more than Stallergenes for one allergen, slightly less for combined allergens (about $60/month for either).
- When the new extract arrives, we will call you in for the first dose. I will rebate you for that visit so that you are not out of pocket. I must see you for the first dose as the drops are made by a different manufacturer. Please bring any boxes of the Stallergenes product with you to that visit.
FAQ
Q. Will I be out of pocket?
A. Yes. For the transport and associated costs to get to me for the first dose of the new product. You will receive a full refund for the Stallergenes drops, and I will rebate you for the visit, so those costs are covered.
Q. Will my allergy treatment take longer?
A. Yes. By a combination of any delays receiving the recalled product initially plus the new delay of receiving the new product.
Q. Is there any danger as a result of using the recalled product?
A. My understanding is that the recall is based on an IT system problem which resulted in “operational disruptions and some incorrect product deliveries” link to Press Release here
Q. Will this delay compromise my treatment?
A. Only in that it will take a few weeks longer over the course of three years. There are no dangers in actually ceasing treatment for any length of time.
Q. What does this mean for you and your staff, Dr Weiner?
A. My staff and I are upset at the inconvenience caused to you. This recall of which I was first notified on 21 Dec 2015 is not due to the actions of my staff or me, but I sincerely apologise to you all for this matter. I am sorry for any inconvenience or any worry about this matter. For those restarting with a different product, I will attempt to get that underway asap.
Q. Does Dr Weiner or his family or his super fund have any financial interest or income at all from Stallergenes-Greer or Inmunotek or any other pharmaceutical company?
A. No
