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Recall Observatory FDA recall evidence

Drug product

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

D-0125-2020

September 06, 2019

Class I

Product summary

Firm
Darmerica, LLC
Event
Event 83734
Status
Terminated
Classification
Class I
Quantity
1.8 kilograms
Official record key
drug-enforcement:D-0125-2020

Official wording

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

Code information: Lot#: a) DL4654A, Exp. 04/27/21; b) DR4654, Exp. 04/27/21 c) DR4654, Exp. 04/27/21

Distribution pattern: U.S.A. Nationwide

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Label Mix-Up