January 17, 2002Elan Pharma Ketoprofen Extended-Release
Capsules Recall Update
- The Food and Drug Administration (FDA) released the following information.
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.
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.
Dissolution failure (at stability testing).
VOLUME OF PRODUCT IN COMMERCE