IGMPI India



Number of drug recalls by USFDA rising

Recalls of pharmaceutical products have increased in recent years, and 2014 is said to be the biggest year for serious drug recalls in the last decade. The reasons for product recalls vary but they are commonly related to packaging defects, contamination of a product, improper testing of a product, or inherent safety problems which could lead a product to harm a patient.

FDA data showed that the last two years have seen almost as many recalls (2,061) as the previous nine years combined (2,217). In 2013, there were 1,225 recalls, a significant jump from the 499 recalls in 2012. In 2012, 2013 and 2014, Class II recalls have constituted 76%, 84% and 77% of all recalls, respectively. Class II recalls were seen for current good manufacturing practice (cGMP) deficiencies.

When a product is recalled by a company, it must submit to FDA various information including the name of its 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. According to FDA's Guidance for Industry: Product Recalls, Including Removals and Corrections, it should 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 how users should protect themselves in the meantime.