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SafetyAlerts
May 11, 2001

Armour Thyroid Recalled

Cincinnati, OH (SafetyAlerts) - The Food and Drug Administration (FDA) said today that Forest Pharmaceuticals, Inc. has recalled Armour Thyroid Tablets because the incorrect NDC number is printed on the blister cards.

This is the first public notice of this Class III recall issued by FDA.

PRODUCT
Armour Thyroid (thyroid tablets, USP) 2 Grain (120 mg), each tablet provides 76 mcg levothyroxine (T4) and 18 mcg liothyronine (T3), 100 tablets, (10) 2x5 unit dose strips, individually blister-sealed tablets, NDC# 0456-0461-63.

A prescription indicated as a replacement or supplemental therapy in patients with hypothyroidism of any etiology, except transiet hypothyroidism during the recover phase of subacute thyroiditis.

Recall #D-194-1.

CODE:
Lot 30012, Exp.12/01.

MANUFACTURER:
Forest Pharmaceuticals, Inc., Cincinnati, Ohio.

RECALLED BY:
Manufacturer, by letters dated 2/16/01. Firm-initiated recall ongoing.

DISTRIBUTION:
Nationwide.

QUANTITY:
553/10/10 tablet strip boxes.

Questions concerning this recall may be directed to the FDA at 1-888-INFO-FDA.

 
Selected Recent Recalls


Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
States for safety reasons!

How many did you hear about?

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The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.