|FOOD AND DRUG
FOR IMMEDIATE RELEASE
Consumer Media: 888-Info-FDA
October 7, 1998
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.
Lot numbers: 25 mcg - 036077A, EXP 12/98 50 mcg - 027027A, 027027B, 027027C, EXP 1/99 300
mcg - 017047A, EXP 3/99.
Vintage Pharmaceuticals, Inc., Charlotte, North Carolina.
Manufacturer, by letter dated May 18, 1998. Firm-initiated recall ongoing.
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.
Firm has no assurance Levothyroxide Sodium products will maintain potency through expiry.