RecallRadar

FDA Drug recall D-0125-2020

Quinacrine Dihydrochloride (98.25%), bulk API product, packaged in a) 500 g NDC# 71052-530-05

On 2019-10-02 the FDA classified a Class I recall of Quinacrine Dihydrochloride (98.25%), bulk API product, packaged in a) 500 g NDC# 71052-530-05 by Darmerica, citing label Mix-Up: Product labeled as Quinacrine Dihydrochloride; however, after testing, identified as Artemisinin.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0125-2020
ClassificationClass I
Statusterminated
Initiated2019-09-06
Published2019-10-02
Last updated2026-09-13 11:52 UTC
CompanyDarmerica
DistributionUS

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

Reason

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

Identifiers

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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0125-2020%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.