MANILA, Philippines – The Food and Drug Administration (FDA) issued warnings to consumers and medical practitioners on Saturday after two pharmaceutical companies recalled batches of medicines, one for heart disease and the other for breast cancer.
In an advisory, the FDA said Abbott Laboratories-Philippines had initiated a voluntary recall of Triflusal 300 mg capsule (Grendis) up to the retail level. Covered by the recall are capsules under batch number H003, with registration number DR-XY30166.
Manufactured by J. Uriach & CIA, S.A., in Barcelona, Spain, in March 2013, the products have an expiry date of March 2016, it said.
Triflusal is an antiplatelet drug also used to treat angina, nonhemorrhagic stroke or transient ischemic attack and reduction of vein graft occlusion after coronary bypass surgery.
The agency said Abbott ordered a recall after receiving a complaint from the Malaysian market that another batch of the product (H005) distributed in that country had a “bad smell.”
An investigation at the manufacturing site found that the smell was due to an increase in one of the impurities, which was then traced to a damage in the refrigeration system, the FDA said.
The health agency said pharmacies in the country should stop selling the product batch, while consumers who had already bought it should return it to where it was purchased. Consumers are also urged to report any adverse reaction caused by the product at report@fda.gov.ph.
In another advisory, the FDA said Fresenius Kabi Philippines Inc. had also started the recall of Paclitaxel 30 mg/1.5 ml Solution for Nanoparticle Injection (Nanoxel).
Covered by the recall are medicines under batch numbers 873TF00103 (nanoxel injection) and 873RX001 (accompanying concentrate of excipients), which were manufactured in January 2013 and with an expiry date of December 2014.
The product is used in the treatment of breast cancer, the agency said. It is packaged in a box containing one vial of paclitaxel solution and one vial of the concentrate.
The recall was prompted by observations that the supposedly clear or colorless concentrate of excipients in the batch had turned yellow even before the end of its shelf life.
Consumers with questions regarding the recall may contact Fresenius Kabi Philippines Inc. safety officer Cristina Aguilar-Cu at 8896492 local 111, or e-mail cristina.aguilar@fresenius-kabi.com