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SafetyAlerts
December 6, 2000

MOVA Pharmaceuticals Corporation Recalls Glyburide Tablets

Caguas, 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.

PRODUCT
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.

Recall #D-050/051-1.

CODE
Lot Numbers: a) ST 43001A EXP 3/01; b) TT 2411A EXP 11/00.

MANUFACTURER
MOVA Pharmaceuticals Corporation, Caguas, Puerto Rico.

RECALLED BY
Manufacturer, by letter dated October 16, 2000. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
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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Health Professional:

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During 2000 there were over
1050 products recalled in the United
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The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.