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SafetyAlerts
January 17, 2002

Elan Pharma Ketoprofen Extended-Release Capsules Recall Update

(SafetyAlerts) - The Food and Drug Administration (FDA) released the following information.

PRODUCT
Ketoprofen Extended-Release Capsules, 200 mg., 100 capsules bottles labeled as Mfd. for: Schein Pharmaceutical, Inc., Mfd by: Elan Pharma Ltd. The product is an Rx only, Recall # D-077-2.

CODE
Lot P0K0252.

RECALLING FIRM/MANUFACTURER
Recalling Firm: Elan Pharmaceuticals Research Corp. Gainesville, GA, by letter on Oct. 19, 2001.

Manufacturer: Elan Pharma Ltd. County Westmeath, Ireland, Firm initiated recall is complete.

REASON
Dissolution failure (at stability testing).

VOLUME OF PRODUCT IN COMMERCE
8,646 bottles.

DISTRIBUTION
Nationwide
.

 
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Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
States for safety reasons!

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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.