October 5, 2000
Urgent: Nationwide Recall Of Etodolac Capsules 300 MG Mixed
With Heart Drug
Davids, PA (SafetyAlerts) - ESI
Lederle has announced a voluntary recall of one lot (number 9991052) containing 4.2
million capsules of its generic Etodolac (Lodine®) Capsules 300 mg. This lot of etodolac
was contaminated with acebutolol hydrochloride, a drug used for high blood pressure and
certain heart problems. According to the company's press release this may, in rare cases,
cause serious or life-threatening side effects in patients with underlying heart
Etodolac is a drug used for arthritis
and pain management. Consumers can identify this product as a white capsule marked in red
with ``300'' on one end and ``59911'' over ``3607'' on the other end. Patients should stop
taking these Etodolac Capsules 300 mg and immediately contact their pharmacist or health
Product from the affected lot was first distributed on October 18, 1999. 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 beta blocker. The maximum amount of acebutolol that could be contained in
one of the recalled capsules is 404 mg.
``We encourage patients who are currently taking etodolac capsules to take immediate
action. They should contact their pharmacist to determine if they received capsules from
the recalled lot. If the lot number cannot be determined, it should be assumed to be from
that lot,'' says Philip J. de Vane, M.D., Company Medical Director. ``Patients who may be
taking capsules from this affected lot or patients who have any medical questions about
this recall should immediately contact their physicians.''
The administration of a cardioselective beta blocker such as acebutolol hydrochloride to
certain patients has the potential to result in serious side effects. Health care
providers who need additional information can call 1-800-747-7016. Patients who have
previously discontinued taking etodolac from the affected lot and have not experienced any
side effects should not be concerned.
Patients should return all affected 300 mg Etodolac Capsules to ESI Lederle by calling
1-800-747-7016. Health care providers and pharmacists are being informed of this recall
via overnight letter. Pharmacies and wholesalers are being notified to return all Etodolac
Capsules 300 mg from lot number 9991052 to ESI Lederle.
PRONUNCIATION: etodolac = etta doe
lak acebutolol = ace a bue tuh lawl.
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