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June 27, 2000

Teva Pharmaceuticals Recalls Glyburide Tablets

Sellersville, PA (SafetyAlerts) - The Food and Drug Administration (FDA) today reported that Teva Pharmaceuticals USA is conducting a recall of certain Glyburide Tablets because of impurity failure (12 month stability testing).

The recalled Glyburide Tablets are:

a) Glyburide Tablets (micronized), USP, 1.5 mg, 100 tablets, unit dose, Rx, with the codes of 114058B EXP 10/00, 114059B EXP 10/00, 114060B EXP 10/00, and 116884A EXP 4/01.

b) Glyburide Tablets (micronized), USP, 3 mg, 100 tablets, unit dose, with the codes of 114061D EXP 4/01, 114062D EXP 4/01, 114063D EXP 4/01, 114517B EXP 5/01, and 116893A EXP 12/01.

These products are indicated as an adjunct to diet to lower the blood glucose I n patients with non-insulin dependent diabetes mellitus (type II) whose hyperglycemia cannot be satisfactorily controlled alone. NDC Numbers: 55953-034-41 and 55953-035-41.

According to FDA, 1,386 units were distributed nationwide.  The firm estimated that 5 percent of product remained on market at time of recall initiation.

This ongoing Class III recall was initiated by the company, by letter on June 5, 2000. This is the first public notice issued by the FDA.

Questions concerning this recall may be directed to the FDA at 1-888-INFO-FDA.
Recall #d-411/412-0

Notice of this product warning was sent via email to SafeMail subscribers June 27, 2000.

Selected Recent Recalls

Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
States for safety reasons!

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