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