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Jul18
Nationwide Voluntary Recall of a Single Manufacturing Lot (Lot 558470A) of Azathioprine Tablets in the U.S. and Puerto Rico Initiated by Roxane Lab, Inc.

00054808425_pack.jpgLast week (13th July), Roxane Laboratories, Inc. started the nationwide recall of a single manufacturing lot of Azathioprine tablets, USP 50 mg, (NDC 00054-4084-25, Lot 558470A, Exp Mar 2009).

Azathioprine tablets are indicated to help prevent rejection in kidney transplant patients, and can also be used in managing severe rheumatoid arthritis.

The recall was conducted because 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.

The following warning has been sent by Roxane Lab to Pharmacists: 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.

Read more at PR Newswire.

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