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U.S. Department of Health and Human Services

Safety

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Etodolac Capsules 300 mg

Results from routine product stability testing of Lot number 9991052 of Etodolac Capsules found that some capsules from this lot may contain a variable and unknown quantity of acebutolol hydrochloride a selective beta blocker, indicated for the treatment of hypertension and ventricular arrhythmias. A small number of capsules available for testing showed a range of acebutolol of 0.4 mg to 135.3 mg per capusle. The maximum amount of acebutolol that could be contained in a capsule of that size is 404 mg.

[October 6, 2000 - Letter - ESI Lederle/Wyeth-Ayerst Labs]