Drug Recalls and Patient Privacy

module 2 chapter 5

What are potential reasons for a drug recall?

• Mislabeling

• inconsistencies in potency

• contamination

• failure to adhere to Good Manufacturing Practices

• new safety concerns

• other issues that pose a public health concern

What is the FDA’s role in drug recalls?

• Oversee the drug company’s recall strategy

• Assess the adequacy of the recall

• Classify the recall

Class I recall

A dangerous or defective product that could cause serious health problems or death

Class II recall

A product that may cause temporary health problems, or pose a slight risk of serious nature

Class III recall

A product that is unlikely to cause any adverse health reaction, but that violates FDA labeling or manufacturing laws.

Technician’s role in a recall

• Monitor FDA alerts

• remove recalled stock and taking actions as directed in the recall

• notifying patients who received recalled meds

Recall classification for a product that is dangerous or defective and could cause serious health problems or death

Class I

Recall classification for a product that may cause temporary health problems, or pose a slight risk of serious nature

Class II

Recall classification for a product that is unlikely to cause any adverse health reaction, but that violates FDA labeling or manufacturing laws.

Class III