ESI Lederle is conducting a nationwide voluntary recall of one lot number of its etodolac capsules 300 mg. The lot number 9991052 consists of some 4.2 million capsules. Capsules in this lot were contaminated during manufacturing with acebutolol hydrochloride, a beta blocker used to treat hypertension and other cardiovascular conditions. Etodolac is indicated for arthritis and pain management.
Pharmacies should return all 300 mg etodolac capsules from lot number 9991052 to ESI Lederle. Patients should stop taking these capsules immediately and return them to ESI Lederle by calling (800) 747-7016. The white capsules are marked in red with "300" on one end and "59911" over "3607" on the other end.
Product from the affected lot was first distributed in October 1999. Results from routine product stability testing of lot number 9991052 found that some etodolac capsules 300 mg contained varying amounts of acebutolol hydrochloride. The maximum amount of acebutolol that could be contained in one of the recalled capsules is 404 mg.
COPYRIGHT 2000 Lebhar-Friedman, Inc.
COPYRIGHT 2000 Gale Group
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