Two lots of quinacrine recalled due to labelling error

The US Food and Drug Administration (FDA) has announced that Darmerica LLC is voluntarily recalling two lots of quinacrine dihydrochloride, a bulk active pharmaceutical ingredient (API) powder packaged in Amber HDPE bottles to the consumer level.

This product is being recalled due to a label mix-up – the product intended for further compounding use by pharmacies labeled as ‘Quinacrine API’ was tested and identified as Artemisinin API, which is used against malaria.

Receiving artemisinin rather than quinacrine could lead to deterioration of disease that is being treated and serious adverse reactions due to prolonged exposure to artemisinin. This would need medical or surgical intervention as well as mistaken evaluation and remediation of adverse reactions, says the company.

Darmerica LLC has said it is notifying its distributors and customers by email and telephone and is arranging for return of all recalled products.

Compounding pharmacies that have the recalled quinacrine dihydrochloride should stop compounding and return it to Darmerica LLC, the company said, and should initiate their own recalls if they manufactured/distributed any products using these two lots.

To date, Darmerica LLC has sais it has not received any reports of adverse events related to this recall.

More information on the product, including lot numbers and how the affected product can be identified, can be found here.

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