July 18, 2000Glyburide Tablets Recalled by
Puerto Rico (SafetyAlerts) - The
Food and Drug Administration (FDA) today reported that MOVA Pharmaceuticals is conducting
a recall of Glyburide Tablets because of blend uniformity failure.
Glyburide Tablets, USP, (micronized), 6 mg, in 100-tablet bottles, Rx indicated as an
adjunct to diet to lower the blood glucose in patients with non-insulin-dependent diabetes
mellitus (type II) whose hyperglycemia cannot be satisfactorily controlled alone.
NDC #55370-506-07. Recall #D-421-0. Class II
Lot #ST2343A EXP 9/00.
MOVA Pharmaceuticals Corporation, Caguas, Puerto Rico.
Manufacturer, by letter on June 12, 2000. Firm-initiated recall ongoing. This is the
first public notice issued by the FDA.
8,407 bottles were distributed.
Notice of this product warning was sent via email
to SafeMail subscribers July 18,
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