August 16, 2000Orasone 5 Tablets Recalled
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
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.
Safety Alerts compiles
comprehensive safety recall information for the United States. SafeMail is a free email
service to warn consumers of faulty products and contaminated foods. For complete
information regarding current recalls, past recalls and timely product warning
notification visit: www.safetyalerts.com.