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SafetyAlerts
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.

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

Recall #D-445-0.

CODE
Lot #89335.

MANUFACTURER
Solvay Pharmaceuticals, Inc., Baudette, Minnesota.

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

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

QUANTITY
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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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.