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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE
Consumer Media: 888-Info-FDA
June 22, 1999

Forest Pharmaceuticals, Inc. Recalls LevothroidÆ Tablets

Cincinnati, OH (SafetyAlerts) - The Food and Drug Administration (FDA) today reported that Forest Pharmaceuticals, Inc. is recalling LevothroidÆ Tablets because of subpotency.

PRODUCT
Forest Levothroid Tablets, Rx indicated as replacement or substitution for diminished or absent thyroid function:
a) LevothroidÆ Tablets, (Levothyroxine Sodium), 25 mcg, in 100 tablet bottles, NDC #0456-0320-01
b) LevothroidÆ Tablets, (Levothyroxine Sodium), 50 mcg, in 100 and 5,000 tablet bottles, NDC #0456-0321-51
c) LevothroidÆ Tablets, (Levothyroxine Sodium), 88 mcg, in 5,000 tablet bottles, NDC #0456-0329-01
d) LevothroidÆ Tablets, (Levothyroxine Sodium), 112 mcg, in 5,000 tablet bottles, NDC #0456-0330-01.

Recall #D-265/268-9.

CODE
Lot Numbers:
a) 10981 and 1992;
b) 109830, 109832, 109833 and 1995;
c) 119829 and 119830;
d) 119835 and 12988.

MANUFACTURER
Forest Pharmaceuticals, Inc., Cincinnati, Ohio.

RECALLED BY
Forest Pharmaceuticals, Inc., St. Louis, Missouri, by letter dated April 2, 1999. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
a) 20,123 100-tablet bottles; b) 7,356 5000-tablet bottles; c) 27,487 100-tablet bottles; d) 14,366 100-tablet bottles were distributed.

 

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.