Darmerica recalls API lots due to label mix-up

By Vassia Barba

- Last updated on GMT

(Image: Getty/Rzarek)
(Image: Getty/Rzarek)

Related tags: Darmerica, Quinacrine, Recall

Darmerica recalls two lots of product labeled as quinacrine, a compound used as a sclerosing agent, which were instead found to contain a treatment for malaria.

Darmerica, a US-based prescription drug repackager, announced the voluntarily recall of quinacrine dihydrochloride, a bulk active pharmaceutical ingredient (API) in powder formulation.

The recall is issued due to label mix-up, with the two affected lots being tested and identified as artemisinin, an API used against malaria.

The products, which were packaged by Amber HDPE Bottles and mistakenly labeled as quinacrine, were distributed to 14 pharmacies across the US for compounding use. Quinacrine is normally used as an antiprotozoal, antirheumatic, intrapleural sclerosing agent.

Receiving artemisinin rather than quinacrine “could lead to deterioration of disease that is being treated, serious adverse reactions due to prolonged exposure to artemisinin, which would need medical or surgical intervention as well as mistaken evaluation and remediation of adverse reactions,”​ the company stated, however, it added that no adverse reports have been reported to date.

The affected products are marked with the lot numbers DR4654A and DL4654A, and had an expiration date of April 27, 2021.

Darmerica will be notifying distributors and customers in order for the affected lots to be returned.


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