May 11, 2001Armour Thyroid Recalled
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.
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.
Lot 30012, Exp.12/01.
Forest Pharmaceuticals, Inc., Cincinnati, Ohio.
Manufacturer, by letters dated 2/16/01. Firm-initiated recall ongoing.
553/10/10 tablet strip boxes.
Questions concerning this recall may be directed
to the FDA at 1-888-INFO-FDA.