June 19, 2001Pharmacia Initiates U.S. Recall
of DELTASONE Tablets
NJ (SafetyAlerts) - Pharmacia
Corporation is recalling 500 count bottles of DELTASONE Tablets
(prednisone tablets, USP), 10 mg, Lot number 29DRB, distributed in the
United States. The recall is based on one report from a pharmacist that a bottle labeled
as DELTASONE Tablets, 10 mg, actually contained DELTASONE Tablets, 5 mg. While this may
have been the only mislabeled bottle, other mislabeled bottles may have been distributed.
To date, the company has received no reports of patients actually receiving an incorrect
dose of DELTASONE as a result of this situation.
DELTASONE is a prescription anti-inflammatory medication used to treat a variety of
disorders. No other lots or countries are affected by this recall.
The effect on patients receiving half the prescribed dose of DELTASONE Tablets depends on
the condition being treated. The effect could be life threatening and could result in
hospitalization or death. Patients who have taken or suspect they may have taken an
incorrect dose of DELTASONE are advised to immediately contact their healthcare provider.
Pharmacia is notifying pharmacies nationwide of this recall. Pharmacists are being asked
to contact any patients who have received a prescription for DELTASONE Tablets, 10 mg
since December 12, 2000, and to instruct them to return any remaining tablets to the
pharmacy for examination. Patients who may have received their prescription by mail order
should call their mail order provider, visit their physician or local pharmacy, or call
the Pharmacia Patient Information Hotline at 888-691-6813 for assistance.
DELTASONE Tablets, 10 mg are white, round and marked "DELTASONE 10." The 5 mg
tablets are white, round and marked "DELTASONE 5." The bottles being recalled,
which contain 500 tablets, are supplied to pharmacies, and are not dispensed directly to
patients. The prescription bottle received by the patient will not likely display the lot
For more information:
Pharmacia Patient Information Hotline:
Health Care Professionals:
800-253-8600, extension 3-8244.