FDA recall D-0125-2020

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 for recall

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

Distribution

U.S.A. Nationwide

Key facts

Status

Terminated

Initiation date

2019-09-06

Report date

2019-10-02

Termination date

2021-02-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Casselberry, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0125-2020