Breast-cancer drugs recalled


The Food and Drug Administration (FDA) has issued an advisory to recall specific batches of tablets used in treating metastatic or Stage 4 breast cancer.

The FDA reported that the affected batches of Nolvadex-D 20 mg tablets [(generic name: Tamoxifen (as citrate)] contain some imperfectly sealed blister packs because of mistakes in packaging.

Nolvadex-D is used for metastatic breast cancer in women and men, as treatment of both node-positive breast cancer in post-menopausal women, and of axillary node-negative breast cancer in women following total or segmental masectomy, axillary dissection and breast irradiation.

It is locally distributed by Astrazeneca Pharmaceuticals Philippines.

The medication is packed in a blister pack containing ten tablets.

The affected batch has an expiry date of May 2016.

The FDA said the flawed packaging might cause safety risks and therapeutic failure and urged hospitals and pharmacies to stop distributing the affected batches.

Retailers who sell the affected drugs were instructed to turn them over to the Marketing Authorization Holder (MAH) for proper destruction to be witnessed by an FDA representative.

The public was also advised to not purchase or use the tablets from the affected batches.



Please follow our commenting guidelines.

Comments are closed.