Darmerica, LLC recalls Quinacrine Dihydrochloride (98.25%), bulk API product, packaged in a) 500 g NDC# 71052-530-05; b) 50 g NDC# 71052-530-5…

Recall date

September 6, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0125-2020

FDA classification

Class I

Brand / firm

Darmerica, LLC

Sold / distributed

U.S.A. Nationwide

Why it was recalled

Label Mix-Up: Product labeled as Quinacrine Dihydrochloride; however, after testing, identified as Artemisinin.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Quinacrine Dihydrochloride (98.25%), bulk API product, packaged in a) 500 g NDC# 71052-530-05; b) 50 g NDC# 71052-530-55, c) 25g NDC# 71052-530-25, Darmerica LLC 198 Wilshire Blvd Casselberry, FL 32707