December 6, 2000UDL Laboratories Inc. Recalls
IL (SafetyAlerts) - The Food and
Drug Administration (FDA) said today that UDL Laboratories Inc. is recalling certain
prednisone tablets because of blend uniformity failure.
This is the first public notice of
this Class III
recall issued by FDA.
Prednisone Tablets, 5 mg, in 1-tablet blister packages,
Rx oral glucocorticoid adrenocortical steroid used in the treatment of primary or
secondary adrenocortical insufficiency. NDC #51079-032-19(RR25).
Lot #OH568 EXP 5/02.
Mutual Pharmaceutical Company, Inc., Philadelphia, Pennsylvania.
UDL Laboratories, Inc., Rockford, Illinois (repacker), by letter on October 23, 2000.
Firm-initiated recall ongoing.
4,076 unit cartons of 25 tablets each were distributed; firm estimated that 30% of the
products remained on the market at time of recall initiation.
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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