Extensive Armour Thyroid Recalls

nobimbo · 05-21-2005, 09:04 AM

May 19, 2005
Extensive Armour Thyroid Recalls
Mary Shomon

A recent report from the Food and Drug Administration has indicated a number of recalls for various potencies of the natural desiccated thyroid drug Armour Thyroid, made by Forest Pharmaceuticals. I'm going to be contacting the manufacturer right away to get more details about the recalls and the extent of the problem and the potential impact on patients, and will report back to you as soon as I can here at the site. In the meantime, here is a list of the specific recalls. If you take Armour Thyroid, you should contact your pharmacy to find out if any refills you've had in the past few months were from the recalled label or lot numbers.

RECALLING FIRM/MANUFACTURER: Amerisource Health Services, Columbus, OH
DATE: April 12, 2005.
REASON: Subpotent: Product may not maintain potency throughout shelf life.
VOLUME OF PRODUCT IN COMMERCE: 58,544/100 tablet bottles.
DISTRIBUTION: Nationwide.
PRODUCT
Armour 30 mg., packaged in 100 tablet bottle containers. Product label contains NDC 0456-0458-01 (FOREST).
Armour 60 mg., packaged in 100 tablet bottle containers. Product label contains NDC 0456-0459-01 (FOREST).
Armour 120 mg., packaged in 100 tablet bottle containers. Product label contains NDC 0456-0461-01 (FOREST).
LOT NUMBERS:
a) Lots 034052, 035064, 035066, 036171, and 036456; b) Lots 034053, 034488, 035065, 035997, 036500, 040423; c) Lots 034051, 035067, 035995, 035996, 036499, 042018.

RECALLING FIRM/MANUFACTURER: Forest Pharmaceuticals, Inc, Earth City, MO, Manufacturer: Forest Pharmaceuticals, Inc, Cincinnati, OH.
DATES: March 17, 2005 and March 31, 2005. Firm initiated recall is ongoing.
REASON: Stability failures.
VOLUME OF PRODUCT IN COMMERCE: 6,891/10/10-tab. unit dose strip boxes; 598,552/100-tab. bottles; 10,984/1,000-tab. bottles; 350/5,000-tab. bottles; 441/50,000-tab. drums.
DISTRIBUTION: Nationwide and Internationally.
PRODUCT
a) Forest Armour Thyroid (thyroid tablets, USP), 1/4 Grain (15 mg), each tablet contains levothyroxine (T4) 9.5 mcg and liothyronine (T3) 2.25 mcg, packaged in 100-tablet bottles, RX, NDC 0456-0457-01.
b) Forest Armour Thyroid (thyroid tablets, USP), 1/2 Grain (30 mg), each tablet contains levothyroxine (T4) 19 mcg and liothyronine (T3) 4.5 mcg, packaged in 100- and 1,000-tablet bottles, 10/10-tablet unit dose strips, and in 50,000-tablet drums for repacking only, RX, NDC 0456-0458-01, -00, -63, and ‚69 respectively.
c) Forest Armour Thyroid (thyroid tablets, USP), 1 Grain (60 mg), each tablet contains levothyroxine (T4) 38 mcg and liothyronine (T3) 9 mcg, packaged in 100-, 1,000-, and 5,000-tablet bottles, 10/10-tablet unit dose strips boxes, and 50,000-tablet drums for repacking only, RX, NDC 0456-0459-01, -00, -51, -63, and ‚69 respectively.
d) Forest Armour Thyroid (thyroid tablets, USP), 1 1/2 Grain (90 mg), each tablet contains levothyroxine (T4) 57 mcg and liothyronine (T3) 13.5 mcg, packaged in 100-tablet bottles, RX, NDC 0456-0460-01.
e) Forest Armour Thyroid (thyroid tablets, USP), 2 Grain (120 mg), each tablet contains levothyroxine (T4) 76 mcg and liothyronine (T3) 18 mcg, packaged in 100- and 1,000-tablet bottles, 10/10-tablet unit dose strip boxes, and 50,000-tablet drums for repacking only, RX, NDC 0456-0461-01, -00, -63, and ‚69 respectively.
f) Forest Armour Thyroid (thyroid tablets, USP), 3 Grain (180 mg), each tablet contains levothyroxine (T4) 114 mcg and liothyronine (T3) 27 mcg, packaged in 100-tablet bottles, RX, NDC 0456-0462-01.
g) Forest Armour Thyroid (thyroid tablets, USP), 4 Grain (240 mg), each tablet contains levothyroxine (T4) 152 mcg and liothyronine (T3) 36 mcg, packaged in 100-tablet bottles, RX, NDC 0456-0463-01.
h) Forest Armour Thyroid (thyroid tablets, USP), 5 Grain (300 mg), each tablet contains levothyroxine (T4) 190 mcg and liothyronine (T3) 45 mcg, packaged in 100-tablet bottles, RX, NDC 0456-0464-01.
LOT NUMBERS:
a) Lot 080301, Exp. May-05; Lot 080302, Exp. May-05, and Lot 080303, Exp. May-05;
b) Unit dose ‚ Lot 100317, Exp. Aug-05; 100-tablet bottles ‚ Lot 060325, Exp. May-05, Lot 080304, Exp. Jun-05; Lot 080329, Exp. Jun-05; Lot 090317, Exp. Aug-05; Lot 100317, Exp. Aug-05; 50,000-tablet drum ‚ Lot 060324, Exp. May-05; Lot 080304, Exp. Jun-05; Lot 090317, Exp. Aug-05; 1,000-tablet bottle ‚ Lot 060324, Exp. May-05; Lot 060325, Exp. May-05; Lot 100317, Exp. Aug-05;
c) Unit dose ‚ Lot 070322, Exp. Jun-05; 100-tablet bottles ‚ Lot 070311, Exp. May-05, Lot 070321, Exp. Jun-05; Lot 070322, Exp. Jun-05; 1,000-tablet bottles - Lot 090308, Exp. Aug-05; 50,000-tablet drums ‚ Lot 070311, Exp. May-05; Lot 110319, Exp. Aug-05;
d) 100-tablet bottles ‚ Lot 040355, Exp. Mar-05; Lot 050315, Exp. Mar-05; Lot 080340, Exp. Jul-05; Lot 100319, Exp. Aug-05;
e) Unit dose ‚ Lot 080330, Exp. Jul-05; 100-tablet bottles ‚ Lot 040334, Exp. Mar-05, Lot 040335, Exp. May-05; Lot 070306, Exp. May-05; Lot 080330, Exp. Jul-05; Lot 100318, Exp. Aug-05; 50,000-tablet drum ‚ Lot 040334, Exp. Mar-05, Lot 070306, Exp. May-05, Lot 080330, Exp. Jul-05; 1,000-tablet bottles - Lot 040334, Exp. Mar-05; Lot 040335, Exp. May-05.
f) Lot 050350, Exp. Apr-05; and Lot 080339, Exp. Jul-05;
g) Lot 040347, Exp. Mar-05;
h) Lot 040348, Exp. Mar-05.

RECALLING FIRM/MANUFACTURER: Rx PAK, Memphis, TN
DATE: March 23, 2005.
REASON: Stability Failure.
VOLUME OF PRODUCT IN COMMERCE: 135,500 units.
DISTRIBUTION: Nationwide.
PRODUCT
a) Armour Thyroid (thyroid tablets, USP), 1/2 Grain (30 mg), each tablet contains levothyroxine (T4) 19 mcg and liothyronine (T3) 4.5 mcg, packaged in 100-tablet bottles, Rx, NDC 0456-0458-01.;
b) Armour Thyroid (thyroid tablets, USP), 1 Grain (60 mg), each tablet contains levothyroxine (T4) 38 mcg and liothyronine (T3) 9 mcg, packaged in 100-tablet bottles, Rx, NDC 0456-0459-01.
LOT NUMBERS:
a) Lot Nos.: 09164, 09330, 09792, 10427, 10918, 11215;
b) Lot Nos.: 09530, 09531, 09787, 10011,10794, 11540, 11541.

http://thyroid.about.com/b/a/171171.htm?nl=1

Note: An email list I belong to posted this info:

Those who talked to Forest were told that the recalls were at the distributor level and that none of the defective product made it to the consumer. It would not hurt to check with your pharmacy, however. The only person who I know got the recalled Armour orders from one of those offshore, no Rx sites.

Linda

Rosie1028 · 05-21-2005, 12:49 PM

Linda,
Thanks you for posting the info on Armour. I have printed it out and I am going to go down and talk to my pharmicist today.

So, why is the drug being recalled??

nobimbo · 05-21-2005, 08:15 PM

Rosie, the article says the Armour was recalled because of inconsistencies in potency (which has happened a lot with Synthroid in the past, but not with Armour that I know of). If you read the note at the bottom of the first post, it says that so far the recalled batches never got past the distributor (except for some of the off shore "no Rx" websites).

Linda

nobimbo · 05-24-2005, 08:08 AM

Understanding the Armour Thyroid Recall of Spring 2005
From Mary Shomon,

May 23 2005

What Patients Need to Know
Last week, I published information about the FDA notification regarding recalls of Armour Thyroid. As more patients hear about this news, there has been increasing concern and confusion regarding the recalls, and whether or not they affect patients who are currently taking Armour Thyroid.
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:

Easy-to-read charts of the recalls
An HTML summary of the recall information
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.

http://thyroid.about.com/od/thyroiddrugstreatments/a/recall2005.htm