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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
March 24, 1999

PRODUCT
Synthroid (levothyroxine sodium, USP) Tablets, Rx indicated as a
replacement or supplement therapy in patients of any age or state
with hypothyroidism of any etiology:
a) Synthroid  Tablets (Levothyroxine Sodium Tablets, USP), 88 mcg
(0.088 mg), 100 tablets in plastic bottles;
b) Synthroid  Tablets (Levothyroxine Sodium Tablets, USP), 100
mcg (0.1 mg), 100 tablets in plastic bottles;
c) Synthroid  Tablets (Levothyroxine Sodium Tablets, USP), 150
mcg (0.15 mg), 100 tablets in plastic bottles;
d) Synthroid  Tablets (Levothyroxine Sodium Tablets, USP), 175
mcg (0.175 mg), 100 tablets in plastic bottles.
Recall #D-136/139-9.

CODE
Lot numbers: a) 880128, 880138, 880148A, 880168A, 880178;b) 1000818; c) 1500388; d) 1750088A, 1750098, 1750118, 1750118A,1750128A, 1750138, 1750148, 1750158.

MANUFACTURER
BASF Pharmaceutical Company, Jayuya, Puerto Rico.

RECALLED BY
Knoll Pharmaceutical Company, Mount Olive, New Jersey, by letteron November 28, 1998. Firm-initiated recall complete.

DISTRIBUTION
Nationwide.

QUANTITY
Lot #         Qty Distributed (100 count bottles)
80128          28,140
880138         37,272
1750088A       32,256
1750098        32,228
1750118        5,388
1750118A       10,920
880148A        25,716
880168A        27,540
1750128A       32,136
1750138        37,992
1500388        3,288
1000818        1,356
880178         13,056
1750148        6,012
1750158        5,784.

REASON
Stability - Product may not maintain potency for the labeledexpiration date due to packaging defect.

 

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.