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SafetyAlerts
February 9, 2001

Pancrelipase 16,000 ECM Capsules Recalled

First public notice issued by FDA of 'completed recall'...

Philadelphia, 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.

PRODUCT
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.

CODE:
Lot 40629 exp. 12/00.

MANUFACTURER:
Mutual Pharmaceutical Company, Inc., Philadelphia, PA.

RECALLED BY:
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.

DISTRIBUTION:
Nationwide.

QUANTITY:
3,125 bottles.

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.

 
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.