February 9, 2001Pancrelipase 16,000 ECM Capsules
public notice issued by FDA of 'completed recall'...
PA (SafetyAlerts) - The Food and
Drug Administration (FDA) said today that Mutual Pharmaceutical Company, Inc. is recalling
Pancrelipase 16,000 ECM Capsules, in 100 count bottles because of dissolution failure.
This is the first public notice of
this Class II
recall issued by FDA.
Pancrelipase 16,000 ECM Capsules, in 100 count bottles. Indicated for use for
patients with pancreatic enzyme deficiency.
NDC is 53489-322-01.
Recall # D-081-1.
Lot 40629 exp. 12/00.
Mutual Pharmaceutical Company, Inc., Philadelphia, PA.
Manufacturer, by letter on October 10, 2000. FDA initiated recall *complete.
*Completed recall: While the FDA has completed
processing of this particular recall, it does not necessarily mean this particular product
has been fully accounted for.
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 February
9, 2001. For more information regarding the SafetyAlerts free email alert service
please click here.
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