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U.S. Department of Health and Human Services

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Deltasone (prednisone) Press Release Jun 2001

FDA posts safety alerts, public health advisories, press releases and other notices from companies as a service to health professionals, consumers and other interested parties. Although FDA approves medical products, FDA does not endorse either the product or the company.

 


This is the retyped text of a letter from Pharmacia Corporation. Contact the company for a copy of any referenced enclosures.


 

FOR IMMEDIATE RELEASE

 

Pharmacia Initiates U.S. Recall of DELTASONE Tablets

Peapack, N.J. (June 18, 2001) – Pharmacia Corporation announced today that, in cooperation with the U.S. Food and Drug Administration, it is conducting a recall in the United States of its 500 count bottles of DELTASONE Tablets (prednisone tablets, USP), 10 mg, Lot number 29DRB. 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 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.

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 number.

Pharmacia Corporation (NYSE:PHA) is a top-tier global pharmaceutical company with a leading agricultural subsidiary. Pharmacia's innovative medicines and other products save lives and enhance health and wellness. Pharmacia's 59,000 people work together with many diverse stakeholders to bring these benefits to people around the world, and to create new health solutions for the future.

 

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For more information

Media Contacts: Pharmacia Patient Information Hotline:

Stephen Lederer 888-691-6813

908-672-6069

Health Care Professionals:

800-253-8600, extension 3-8244