ARMOUR RECALL BECAUSE OF LABEL ERROR

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February 09, 2011

If you have 1/2 grain (30 mg) tablets, a label error caused some one grain tablets (60 mg) to be labeled as 1/2 grain tablets (30 mgs). That would mean you could be overdosing yourself if you are taking 1/2 grains. Both sizes need to be returned to your pharmacist with this information and exchanged. i.e. COPY THIS when you take them back.

NOTE: they would be Lot No: 1077413 with an expiration of 9/30/2011 This is what your pharmacist would need to know.

PRODUCT

Armour Thyroid (thyroid tablets, USP), 1/2 grain (30 mg) , each tablet contains 19 mcg levothyroxine (T4) and 4.5 mcg liothyronine (T3), 100-count bottle, NDC 0456-0458-01. Recall # D-231-2011

CODE Lot No: 1077413, Exp. 9/30/2011

RECALLING FIRM/MANUFACTURERRecalling Firm: Forest Pharmaceuticals Inc., Earth City, MO, by telephone and letters on October 6, 2010. Manufacturer: Forest Pharmaceuticals Inc., Cincinnati, OH. Firm initiated recall is ongoing.

REASONLabeling: Label error on declared strength; some bottles are mislabeled as containing 1/2-grain tablets but actually contain 1-grain tablets. The entire lot is being recalled even though some bottles are labeled correctly because bottles of 1/2-grain and 1-grain could be shrink-wrapped together.

VOLUME OF PRODUCT IN COMMERCE31,172 bottles approx.

DISTRIBUTIONNationwide, PR, Belgium and the United Kingdom

http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm242808.htm

Page said:

Feb 09, 11 at 10:23 pm Armour has been recalled many times over the years. Many pharmacists order prescription drugs in large quantities and decant them into their own bottles with their own labels. While their label will have the manufacturer, it usually does not have the lot number or any other identification for what batch it comes from. Unless, the pharmacist contacts the customers, the customers have no way of knowing if they are taking an Rx that has been recalled. Whenever possible, request your Rx in the original manufacturer's bottle. If that is not possible, request the pharmacist put the lot number on their label.