FDA Sets Defective Products' Alert

Article excerpt

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. …