FDA orders recall of 4 drugs

MANILA, Philippines - The Food and Drug Administration (FDA) has ordered the recall of four products of pharmaceutical firm Eli Lilly (Philippines) Inc. after they were found to be unregistered.

In Advisory No. 2013-055, FDA acting director Dr. Kenneth Hartigan-Go said that based on their investigation, the products did not have “valid Certificates of Product Registration, hence, unregistered.”

The products are anti-depressant Prozac (flouxetine) 20 milligram capsule; Strattera (atomoxetine) in 10 mg, 18 mg, 25 mg, 40 mg and 40 mg capsules, which are used to treat attention deficit hyperactivity disorder; Zyprexa Zydis (olanzapine) 10 mg orodispersible tablet; and Zyprexa IM (olanzapine) 10 mg powder, both used to treat behavior disorder.

Go said Eli Lilly is “mandated” to recall the products under Bureau Circular No. 8 s. 2001, or the “guidelines to be observed on the implementation of product recall system.”

“Physicians are hereby warned against prescribing these products. Also the public is advised to refrain from buying and using these products,” he added.

Go has directed all FDA inspectors to ensure that the products “will not be found in Eli Lilly’s distributor’s warehouses and in retail drugstores after Eli Lilly has concluded the recall process.”