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August 16, 2000

Orasone 5 Tablets Recalled

Marietta, GA (SafetyAlerts) - The Food and Drug Administration (FDA) stated in a report released yesterday that Solvay Pharmaceuticals, Inc. is conducting  a recall of its Orasone 5 Tablets because of dissolution failure (18 month stability).

This is the first public notice of this Class III recall issued by the FDA.

Orasone(tm) 5 Tablets (Prednisone Tablets, USP), 5 mg, in bottles of 1,000, Rx anti-inflammatory agent.

Recall #D-445-0.

Lot #89335.

Solvay Pharmaceuticals, Inc., Baudette, Minnesota.

Solvay Pharmaceuticals, Inc., Marietta, Georgia, by letter on June 26, 2000. Firm-initiated recall ongoing.

California, Colorado, Connecticut, Minnesota, Missouri, New York, North Dakota, Ohio, South Dakota, Tennessee.

3,765 bottles were distributed.

Questions concerning these recalls may be directed to the FDA at 1-888-INFO-FDA.

Selected Recent Recalls

Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
States for safety reasons!

How many did you hear about?

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