Drug firm fined P16M
MANILA, Philippines—The Food and Drug Administration (FDA) has slapped a pharmaceutical firm with a P16-million administrative fine and ordered the recall of 15 of its products that were either unregistered or had falsified product registrations.
In an advisory dated May 6 but was posted on the FDA website late Thursday, the FDA said it has fined Eli Lilly Philippines for importing and distributing unregistered products.
“Eli Lilly has been directed to initiate steps in informing the patients and prescribers to look for alternative products. Physicians are hereby warned against prescribing these products while the public is advised to be vigilant and refrain from buying and using them,” said FDA acting director general Kenneth Hartigan Go.
Covered by the recall order for being unregistered or having falsified product registrations were:
• Cialis 20 mg tablet;
• Cymbalta 30 mg capsule;
• Humalog 100 units per ml solution for injection;
• Humalog Kwikpen 100 u/ml solution for injection;
• Humalog Mix 25 Kwikpen 100 u/ml solution for injection;
• Humalog Mix 25;
• Humalog Mix 50 Kwikpen;
• Stratterra 10 mg capsule;
• Stratterra 18 mg capsule;
• Stratterra 2 g capsule;
• Straterra 40 mg capsule;
• Strattera 60 mg capsule;
• Prozac 20 mg capsule;
• Zyprexa Zydis 10 mg Orodispersible tablet, and
• Zyprexa Intramascular 20 mg powder for injection.
In a statement sent to reporters, Eli Lilly Philippines said it has submitted required documentation related to its certificate of product registration and has been working with the FDA on their product license renewals.
The company also clarified that the information about its registered and unregistered products in the FDA advisory is different from that of the company records. It is, however, working with the FDA to clarify the disseminated information.
“Lilly deeply regrets the impact experienced by patients who depend on our medicines while the product license renewal process is [being] completed,” the company said.
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