Drug Recalls

Pharmaceutical companies occasionally need to recall, or remove from market, their products. Some common recalls are due to packaging defects, contamination, poor or improper testing, or a safety problem that can harm or kill a person.

The Food and Drug Administration has created a three tiered system to classify recalls. The FDA will classify the recall when notified by the company. The types of recalls are listed below.

• Class I Recall: a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
• Class II Recall: a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
• Class III Recall: a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.

When a product is recalled by a company, it must provide certain information for the FDA’s review. This information included the name of the product, its National Drug Code (NDC), its approval number, lot/unit number, its strength and route of administration, the extent of the recall, and a reason for the recall. That last bit of information should, according to FDA’s “Guidance for Industry: Product Recalls, Including Removals and Corrections”, include a detailed explanation of how the product is either defective or violative, how it affects the safety of the product, the nature of the defect, and any information on what the consumer should do to protect themselves.