Roxane Laboratories Initiates a Nationwide Voluntary Recall of a Single Manufacturing Lot of Azathioprine Tablets in the U.S. and Puerto Rico

Date of Recall

2006-07-13

Recall Details

Columbus, Ohio -- July 13, 2006 -- Roxane Laboratories, Inc., announced today that it is conducting a nationwide voluntary recall of a single manufacturing lot of Azathioprine tablets, USP 50 mg, (NDC 00054-4084-25, Lot 558470A, Exp Mar 2009). Azathioprine is used to help prevent rejection in kidney transplant patients, and can also be used to manage severe rheumatoid arthritis.

It was discovered that a single bottle of Azathioprine tablets from lot 558470A contained Methotrexate tablets USP 2.5 mg. While we believe this issue may be limited to this single bottle, which was not dispensed to a patient, the decision was made to recall manufacturing lot 558470A in order to preclude any possibility of another such bottle being dispensed or used.

Roxane Laboratories' number one priority is for the safety of patients who use our products. Due to the potentially serious or life-threatening health affects that could occur if patients ingest the incorrect medication, Roxane Laboratories is voluntarily recalling the single manufacturing lot of Azathioprine tablets. If Methotrexate 2.5 mg tablets are taken in place of Azathioprine 50 mg tablets in accordance with dosing instructions that may be prescribed for Azathioprine, serious toxic effects may occur. Effects may include decreased resistance to infection, mouth ulcers, reduced blood counts, vomiting, diarrhea, liver, kidney or lung injury. There have also been reports of death at high doses of Methotrexate, such as might result from a substitution of Methotrexate 2.5 mg tablets for Azathioprine 50 mg tablets.

Information has been sent to Pharmacists alerting them of the details pertaining to this recall. As described in these recall communications, pharmacists who may have dispensed Azathioprine tablets to patients from manufacturing lot 558470A are instructed to contact those patients to assure they did not inadvertently receive Methotrexate tablets.

ADVICE FOR PATIENTS TAKING AZATHIOPRINE TABLETS:

If you have been notified by your pharmacist that you may have received medication from this recalled lot, please return your Azathioprine to your pharmacist.

If you have NOT been notified by your pharmacist, then please take the following steps to verify that you have not received Methotrexate tablets in your Azathioprine prescription:

1. Visually inspect your Azathioprine tablets.
2. DO NOT TAKE Azathioprine tablets marked with number 54 323.
3. If you have Azathioprine tablets marked with number 54 323 immediately contact your pharmacist or physician.
4. Patients are advised to contact their pharmacist or physician if they have any questions about their prescription or medication.
5. Requests for additional information should be referred to Roxane Laboratories Technical Product Information at 800-962-8364.

Roxane Laboratories is working with the US FDA on this voluntary recall. The products discussed in this press release are available by prescription only, and to date no injuries have been reported in relation to this issue.

Pharmacists and wholesalers that have any bottles of Azathioprine manufacturing lot 558470A have been instructed to discontinue distribution and use of this lot immediately and contact Capital Returns at 800-950-5479 (menu option 1) for any questions regarding the recall returns. Requests for additional information should be referred to Roxane Laboratories Technical Product Information at 800-962-8364.

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