ESI Lederle is voluntarily recalling lot number 9991052 of Etodolac capsules 300 mg, a generic version of Lodine (etodolac capsules and tablets). Etodolac, a nonsteroidal anti-inflammatory drug, is used for management of signs and symptoms associated with osteoarthritis and rheumatoid arthritis.
Results from routine product stability testing of this lot found that some capsules may contain a variable quantity of acebutolol hydrochloride (Sectral), a selective beta blocker, indicated for the treatment of hypertension and ventricular arrhythmias. The administration of a cardioselective beta blocker such as acebutolol has the potential to result in serious adverse health effects in certain patients.
The capsule at issue is white, marked in red with "300" on one end and "599 11 " over "3607" on the other end. Lot number 9991052 was manufactured in September 1999 and was shipped October 18, 1999, through August 31, 2000.
Patients should return all affected capsules to ESI Lederle by calling 1 800-747-7016. For more information, health care providers may call ESI Lederle at 1-800-747-7016.
Copyright Springhouse Corporation Nov 2000
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