FDA warns of ‘unnecessary risk’ as AmEx pulls lots of Avastin over sterility concerns

By Ben Hargreaves contact

- Last updated on GMT

(Image: Getty/Siphotography)
(Image: Getty/Siphotography)

Related tags: AmEx Pharmacy, Pacifico National, Genentech, Avastin, Roche, Recall

The US FDA has followed up a public recall request to AmEx by hosting the manufacturer’s notice of a voluntary recall of Avastin, after sterility concerns.

A week ago the US Food and Drug Administration (FDA) notified​ patients and healthcare professionals that AmEx Pharmacy, also known as Pacifico National, had “refused to recall all sterile drug products.”

This announcement followed an inspection of AmEx’s facility, where the agency found that conditions could lead to the possible contamination of sterile products and concluded that such products “pose unnecessary risks due to significant quality and sterility concerns.”

As a result, the FDA recommended that AmEx issue a voluntary recall of all unexpired sterile drugs and to cease the manufacture of sterile products until corrective action had been taken.

The statement outlined, “However, AmEx Pharmacy declined to initiate a recall of all unexpired drugs intended to be sterile and has not provided adequate assurances regarding the sterility and quality of its remaining and newly manufactured products.”

Regarding the risks that non-sterile drugs pose, particularly the intraocular medication that AmEx specializes in, the agency suggested that they can lead to infections and partial or total visual function.

AmEx instigates action

Three days following the FDA’s public notice, AmEx issued a voluntary recall​ of unexpired lots of bevacizumab 1.25mg/0.05mL 31G injectable and bevacizumab 2.5mg/0.1ml Normject TB injectable.

The company’s announcement stated that the lots were being recalled “out of an abundance of caution following an FDA inspection.”

The FDA noted in its previous public notice that it had already received reports of adverse events associated with the use of AmEx’s products – though it did not specify whether this was associated with the bevacizumab products.

Bevacizumab is known by its brand name of Avastin, which is a product sold by Genentech, a subsidiary of Roche. The product will no longer be patent protected in 2020 in the US, though biosimilars to the product have already been approved in both the US​ and the European Union​ (EU).

Related topics: Markets & Regulations, Facilities

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