December 14, 1999Med-Pro, Inc. Recalls Diabeta
Lexington, NE (SafetyAlerts) - The Food and Drug
Administration (FDA) today reported that Med-Pro is recalling Diabeta® (Glyburide) 5mg,
for use as an adjunct to diet to lower the blood glucose in patients with non
insulin-dependent diabetes mellitus (Type II), because the immediate bottle label shows
two strengths 5 MG and 25 MG.
This Class II recall was initiated by
the company, by telephone on September 27, 1999, and by letter dated September 28, 1999.
This is the first notice the FDA has issued to the general public of the recall. The
FDA considers this recall complete.
The recalled Diabeta® (NDC
#0039-0052-10) was distributed in New York, for sale by prescription in 100 tablet bottles
and has the lot number 0017181, EXP 6/2001.
Questions concerning this recall may
be directed to the FDA at 1-888-INFO-FDA.
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