FDA fines pharmaceutical firm P16M over unregistered products

The Food and Drug Administration has fined pharmaceutical firm Eli Lilly Philippines P16 million and has ordered the recall of 15 of its products of after finding they were unregistered or had falsified product registrations.

 

"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," FDA head Kenneth Hartigan-Go said in Advisory 2014-034.

 

While the FDA advisory was dated May 6, it was posted on the FDA website only on Thursday.

 

Covered by the recall order for being unregistered or having falsified product registrations were:

 

 

Products in the list still in the market are to be returned to the Zuellig Pharma Corp. office in Parañaque City.

 

Hartigan-Go noted the safety, efficacy and quality of these products "need to be established anew before they are authorized to he marketed."

 

"The continuous activities of importation, distribution and selling of the enumerated unregistered products and/or with falsified product registration are prohibited and punishable under the Food and Drug Administration Act of 2009," he added.

 

Allowed products

 

Meanwhile, Hartigan-Go said only the following Eli Lilly products have certificates of product registration:

 

 

The FDA advised the public to email it at info@fda.gov.ph for inquiries. Those who want to report unregistered health products and adverse reactions after using any health product may email the FDA via report@fda.gov.ph. — Joel Locsin/JDS, GMA News