I had an opportunity to talk today with a company spokesperson for Forest Laboratories, the manufacturer of Armour Thyroid, to clarify the issue.
It's important to start with a bit of background regarding the drug manufacturing process. Every time a batch (known as a "lot") of any drug is made, the drug manufacturer holds back a small number of samples from that lot, and keeps it in reserve instead of distributing it. These samples are for quality control puposes, and periodically, the manufacturer will pull out those samples and test them for quality. If a quality, potency, or other problem is found with a particular lot, the manufacturer will recall that lot.
If the recall is not an issue of consumer safety, the recall will typically be from wholesalers. In some cases, wholesalers will then get back the recalled drugs from pharmacies. Only when a drug recall is an issue of serious consumer safety does a recall involve letters sent from the drug manufacturer to pharmacies and/or patients.
How does the Armour Thyroid recall fit in? As with all drugs, Armour's manufacturer, Forest Laboratories, holds back samples from every lot it produces, and periodically tests those samples. When Armour Thyroid is manufactured, it has a 24-month expiration date. That means that Armour Thyroid should maintain its potency for a full two years.
What Forest found in recent sample testing was that there were several lots of Armour Thyroid that were not maintaining full potency. These lots were manufactured between March 2003 and August of 2003, and therefore they were set to expire between March 2005 and August of 2005.
Rather than recall just those several lots in which potency problems were discovered, the manufacturer decided that they would avoid any potential problems and recall all of the Armour made during that particular timeframe in 2003. They considered this preventative, since the product manufactured between May and August 2003 was due to expire in 2005 anyway, and there was very little of the product actually on shelves anyway.
While the list of lot numbers and quantity of product seems extensive, and makes it appear as if the recall of Armour Thyroid is quite massive, it's actually a small recall, as most of the Armour Thyroid in the listed lots has already been distributed and used by consumers in the past two years. According to the company, very little product from these lots is actually still in distribution. Since the recall was announced, only a few dozen units of Armour Thyroid affected by the recall have actually been returned from wholesalers.
As many patients and practitioners are aware, in the past year, some manufacturing changes made by Forest resulted in severe backlogs and shortages of the drug for many months. During those months, almost all of the Armour that was in the distribution and pharmacy pipeline was used up. Most of the recalled product was, therefore, sold long ago and used by consumers, leaving very little of the recalled Armour actually unused and in the market.
What Patients Can Do
If you do by chance have some of the recalled product, you will not be informed by your pharmacist, because this level of recall only requires that the manufacturer notify the wholesalers. Wholesalers are not required to notify pharmacies, and pharmacies are not required to notify you. Your pharmacy may not even be aware of the recall.
To determine if you have any of the recalled product, you will need to check with your pharmacist, and provide the pharmacist with the specific lot numbers of the recalled Armour Thyroid.
To help, here are some resources:
Since your pharmacist may wish to see the actual FDA report, you should ideally print off this 3-page formatted FDA Recall Report in PDF format.If you have recalled Armour, tell your pharmacist you would like replacement product. The pharmacy can return the recalled product to their distributor for a credit, and you can receive a fresh batch of Armour. (Don't contact Forest, because they can't issue replacement Armour to you directly. They can only issue a credit and supply new product to wholesalers and pharmacies.)
According to Forest, there are no shortages or back orders on any size or strength of Armour Thyroid; all products should be fully available.
Mary Shomon, About.com's Thyroid Guide since 1997, is a nationally-known patient advocate and best-selling author of 10 books on health, including "The Thyroid Diet: Manage Your Metabolism for Lasting Weight Loss," and "Living Well With Hypothyroidism." Click here for more information about Mary Shomon.
