Waves of sartan recalls lead to new FDA draft guidance

By Ben Hargreaves contact

- Last updated on GMT

(Image: Getty/Tumsasedgars)
(Image: Getty/Tumsasedgars)

Related tags: Sartan, Recall

The US FDA has issued draft guidance on the process of voluntary recalls, after a series of recalls involving sartan contamination with carcinogenic impurities.

In a new draft guidance, the US Food and Drug Administration calls for companies to be prepared for any potential recalls as it focuses its recommendations on three key areas: training, record keeping, and procedures.

  • Training​: Proper training of personnel is perhaps one of the most important elements to effectively executing a recall. The draft guidance provides recommendations for companies who manufacture or distribute FDA-regulated products to adopt in readying their staff for potential recall situations
  • Record keeping​: Thorough and organised record keeping is especially important as the agency continues its efforts to improve recalls through product traceability by tapping into modern approaches, such as blockchain technology, to further advance our mission of protecting public health
  • Procedures​: Written recall initiation procedures help to minimise delays created by uncertainty. For companies that initiate a recall, using initiation procedures can help reduce the amount of time a defective or potentially harmful product is on the market and that in turn reduces the potential exposure to consumers

Beyond helping companies initiate a voluntary recall more efficiently, the FDA stated that it has begun providing information to consumers more readily through the web listing of all recalls.

The agency references the recent contamination of ‘sartan’ products​ as an example of where it has been proactive in providing consumers with updates. This issue began with valsartan products, before extending to include losartan and irbesartan-containing medicine.

Both the FDA and European Medicines Agency​ have been providing regular updates on the development of the investigation into contaminated products.

Issues of contamination have led to a number of recalls taking place, to an extent that the FDA has had to prioritise the review of new generics​ for such products due to the shortages created on the market.

The agency concluded its announcement on voluntary recalls​ by stating that “collective efforts will help the agency to prevent future recalls and work quickly with companies to remove products from the market when an issue does arise.”

The new guidance is currently open for comment until June 24, 2019, at which point the FDA will look to finalise the document.

Related topics: Regulatory & Safety, Regulations, QA/QC

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