December 6, 2000Mutual Pharmaceutical Company
Inc. Recalls Prednisone Tablets
PA (SafetyAlerts) - The Food and
Drug Administration (FDA) said today that Mutual Pharmaceutical Company 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 5 mg Tablets, USP, in 100 and 1000-count bottles, 12 bottles per
innerpack, and 12 innerpacks per carton, sold under the Mutual label in 1000-count bottles
(NDC #53489-138-10), and the URL label in 100-count bottles (NDC #0677-0117-01), intended
for endocrine disorders, rheumatic disorders, collagen diseases, dermatological diseases,
allergic states, ophthalmic diseases, respiratory diseases, hematological disorders,
neoplastic diseases, edematous states, and gastrointestinal diseases.
Lot Numbers: 42129 EXP 12/02 and 42130 EXP 12/02.
Mutual Pharmaceutical Company, Inc., Philadelphia, Pennsylvania.
Manufacturer, by letter on October 12, 2000. Firm-initiated recall ongoing.
3,857 100-tablet bottless and 6,391 1000-tablet bottles. Firm estimated that 10% of the
recalled lots remained on 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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