Drugs for heart ailments, breast cancer recalled from market

MANILA, Philippines - The Food and Drug Administration (FDA) yesterday cautioned the public against certain batches of medicine for heart ailments and for breast cancer, which were recalled from the Philippine market following complaints.

A batch of Trifusal 300 mg capsule (Grendis), a medicine for heart ailments, has been recalled following complaints of “bad smell” from Malaysian consumers, the FDA said.

Trifusal is an antiplatelet drug indicated for secondary prevention after a first coronary or cerebrovascular ischemic event of myocardial infarction, stable and unstable angina, non-hemorrhagic stroke or transient ischemic attack, and reduction of vein graft occlusion after bypass surgery.

In an advisory, FDA director-general Kenneth Hartigan-Go said that Abbott Laboratories (Philippines) has initiated the “voluntary recall of Trifusal 300 mg capsule up to retail level.”

The affected product has registration number of DR-XY3-166, batch number H003, and expiry date of March 2016.

Go said that Abbott received complaints from the Malaysian market that another batch of the product, H005, which had been distributed to Malaysia, had a bad smell.

“The result of the investigation of the manufacturing site concluded that the bad smell was due to an increase of one known impurity name HTB, 4-trifluoromethylsalicylic acid (also known as 2-Hydroxy-4- triflouromethyl) Benzoic acid,” the FDA official said.

The increase in the impurity is related to a damage of the refrigeration system of the equipment used in the manufacturing process of the active pharmaceutical ingredient.

“The batch number H003 distributed in the Philippines was manufactured using a different lot number of active pharmaceutical ingredient (Trifusal) from that of the complaint batch H005. However, the active pharmaceutical ingredient manufacturing site confirmed that batch H003 was impacted by the same event (damage of refrigerator system),” Go said.

The FDA has advised all pharmacies to locate and remove the affected batch of medicine from their facilities. Consumers are also advised not to use the affected product and return it to where it was purchased.

In another FDA advisory, Go said that Fresenius Kabi Philippines Inc. is initiating a “voluntary recall of Paclitaxel 30mg/1.5mL Solution for Nanoparticle Injection (Nanoxel) due to Out of Specification result on the physical appearance of the accompanying Concentrate of Excipients.”

“The Concentrate of Excipients was observed as yellow liquid which is different from the registered specification (clear colorless) before the completion of the approved shelf-life,” he noted.

Paclitaxel is used in treating breast cancer after the failure of combination chemotherapy for metastatic disease or relapse within six months of adjuvant chemotherapy. It is packaged in a box containing one vial of Paclitaxel solution and one vial of Concentrate of Excipients.

“Distributors, retailers, hospitals, pharmacies, or clinics that have the affected batch of Paclitaxel 30mg/mL solution for Nanoparticle Injection (Nanoxel) and accompanying Concentrate of Excipients are instructed to stop the use and discontinue from further distribution,” Go said.