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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
October 7, 1998

PRODUCT
Levothyroxide Sodium Tablets, 25, 50 and 300 microgram, Rx used as replacement or supplemental therapy in patients with hypothyroidism, under the Qualitest and Vintage labels. Recall #D-246-8 and D-263/264-8.

CODE
Lot numbers: 25 mcg - 036077A, EXP 12/98 50 mcg - 027027A, 027027B, 027027C, EXP 1/99 300 mcg - 017047A, EXP 3/99.

MANUFACTURER
Vintage Pharmaceuticals, Inc., Charlotte, North Carolina.

RECALLED BY
Manufacturer, by letter dated May 18, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
25 mcg:   895 bottles;
50 mcg:   557 bottles of lot 027027A, 284 bottles of lot 027027B and 952 bottles of lot 027027C;
300 mcg:  1,852 bottles were distributed.

REASON
Firm has no assurance Levothyroxide Sodium products will maintain potency through expiry.

 

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.