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December 28, 1999

Forest Pharmaceuticals Recalls Forest Levothroid Tablets

Cincinnati, OH (SafetyAlerts) - The Food and Drug Administration (FDA) today reported that Forest Pharmaceuticals, Inc. is recalling Forest Levothroid Tablets because they were found to be sub-potent.

This ongoing Class II recall was initiated by the company verbally and by letter on November 3, 1999.  This is the first public notice issued by the FDA.

Forest Levothroid Tablets (levothyroxine sodium tablets, USP), a prescription indicated as replacement or substitution therapy for diminished or absent thyroid function have been recalled as follows:

a) LevothroidÆ Tablets (Levothyroxine Sodium), 75 mcg, 100 count. NDC #0456-0322-01
Lot Numbers: 10984, 10985, 11981, and 11982 EXP 11/00
b) LevothroidÆ Tablets (Levothyroxine Sodium), 100 mcg, 100 count. NDC #0456-0323-01
Lot Numbers:  19914, 19912, and 19913 EXP 01/01
c) LevothroidÆ Tablets (Levothyroxine Sodium), 125 mcg, 100 count. NDC #0456-0324-01
Lot Numbers:  109810 EXP 10/00, 19917 EXP 01/01, 1991 EXP 07/00, 19919 EXP 01.01, and 19918 EXP 01/01
d) LevothroidÆ Tablets (Levothyroxine Sodium), 137 mcg, 100 count. NDC #0456-0331-01
Lot Numbers:  109811 EXP 10/00, and 2994 02/01
e) LevothroidÆ Tablets (Levothyroxine Sodium), 150 mcg, 100 count. NDC #0456-0325-01
Lot Numbers:119842 EXP 12/00 and 19926 EXP 01/01
f) LevothroidÆ Tablets (Levothyroxine Sodium), 175 mcg, 100 count. NDC #0456-0326-01
Lot Numbers: 109813 EXP 12/00 and 119844 12/00
g) LevothroidÆ Tablets (Levothyroxine Sodium), 200 mcg, 100 count.
NDC #0456-0327-01. Recall #D-146/152-0.
Lot Numbers:  99813 EXP 10/00

Over 251,000 bottles were distributed Nationwide.

Meet others who may share your concerns regarding Thyroid disease at About.com - Thyroid area

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

 
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