MANILA, Philippines — The Food and Drug Administration (FDA) on Friday set guidelines on the transmission of information between FDA and other government agencies relating to rapid alerts on the recall and withdrawal of health products intended for humans and animals, but are defective or are fake.
The FDA said it will have a written procedure in the issuance, receipt and handling of notifications for defective products, batch recalls and other rapid alerts.
It said the rapid alert system will transmit “only those alerts whose urgency and seriousness cannot permit any delay in transmission.”
An assessment will be made to determine the seriousness of the defect, its potential harm to the patient, animals, consumers, operators and the environment.
The FDA has established three classes of classification in the recall of defective health products.
Class I defects are those which are potentially life threatening. Under this, a rapid alert notice will be sent. These include wrong products whose labels and contents are different; correct product but wrong strength; microbial contamination of sterile injectable or ophthalmic product; chemical contamination with serious medical consequences; mix-up of some products with more than one container involved; and wrong active ingredient in a multi-component product with serious medical consequences.
Those that can cause illness or mistreatment and outside the scope of Class I are classified as Class II defects. These defects are mislabeling; missing or incorrect information on the insert or leaflet; microbial contamination of non-injectable, non-ophtalmic sterile product with medical consequences; chemical and physical contamination; mix-up of products in containers; non-compliance with specification; and faulty closure with serious medical consequences.
Class III defects are those that may not pose significant hazard to health and withdrawal of the product is done for a different reason. These include faulty packaging like wrong or missing batch number of expiry date; faulty closure; and contamination like microbial spoilage or dirt.
In addition, the FDA said the rapid alert system may also be used to notify authorities of the recall of products or an embargo on the distribution of products following the suspension or withdrawal of a manufacturing, importation or wholesale authorization.
Under the system, the FDA will issue the alert if the product is first identified in the Philippines. It will lead in the investigation of the defect and issue appropriate alert.
All alerts will be sent via email.
FDA Sets Defective Products’ Alert | The Manila Bulletin Newspaper Online
