Prescription Drug Recalls

Pharmaceutical manufacturers must follow very rigorous clinical testing. The new drug approval supervised by the U.S Food and Drug Administration (FDA) is an exacting process.

Yet prescription drug recalls still occur.

The prescription drug recall process differs significantly from over-the-counter drug recalls, particularly as prescription drug distribution can be tracked.

Yet that doesn’t necessarily make it easier to effectively manage a prescription drug recall.

Prescription drug recalls usually occur when serious adverse drug reactions (commonly called side effects) causes disability, hospitalization, birth defects, or death. Drug recalls are classified as Class I, Class II, or Class III depending on the level of risk to public safety. Prescription drug recalls involve drugs delivered to the body in all forms: tablets, skin patches, liquids, sprays, inhalants, etc.

Less serious drug “market withdrawals” occur when the FDA deems a minor regulatory violation important enough to remove the product from the market. The FDA does not penalize companies for these prescription drug market withdrawals that may be due to faulty drug labeling or inadequate “black box warnings.”

However, when there is a drug recall of any sort, consumer perceptions are usually so negative that the possibility of brand and reputational damage, not to mention burdensome recall costs, is very real. Future sales are jeopardized no matter what the manufacturers and regulators do to reassure the public.

Whether a drug recall involves danger to public health and safety, or simply a point of purchase labeling or marketing issue, the best recall strategy is always to clear the shelves as quickly as possible in order to maintain public trust.

Pharmaceutical manufacturers must have a recall strategy in place well ahead of need. It must include a well-tested recall plan for proper consumer notification as well as the withdrawal and disposal of recalled products. For more information, visit www.fda.gov.