December 6, 2000MOVA Pharmaceuticals Corporation
Recalls Glyburide Tablets
Puerto Rico (SafetyAlerts) - The
Food and Drug Administration (FDA) said today that MOVA Pharmaceuticals Corporation is
recalling certain glyburide tablets because some tablets are subpotent while others suffer
from of blend uniformity non-conformance with RSD specification.
This is the first public notice of
this Class III
recall issued by FDA.
Glyburide Tablets, USP (micronized), Rx, indicated as an adjunct to diet to lower
the blood glucose in patients with non-insulin-deptendent diabetes mellitus (Type II)
whose hyperglycemia cannot be satisfactorily controlled by diet alone:
a) Glyburide Tablets, 6 mg, in 100-count bottles,
NDC #55370-506-07 - Blend uniformity non-conformance with RSD specification.
b) Glyburide Tablets, 1.5 mg, in 100-count
bottles, NDC #55370-146-07 - Subpotency.
Lot Numbers: a) ST 43001A EXP 3/01; b) TT 2411A EXP 11/00.
MOVA Pharmaceuticals Corporation, Caguas, Puerto Rico.
Manufacturer, by letter dated October 16, 2000. Firm-initiated recall ongoing.
10,615 bottles were distributed.
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 SafetyAlerts subscribers December
6, 2000. For more information regarding the SafetyAlerts free email alert service
please click here.
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