FDA Recall D-0125-2020

Darmerica, LLC · Casselberry, FL

Class I — life-threatening Terminated 518 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.

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

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

Quantity: 1.8 kilograms

Reason for recall

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

Recall record

Recall number: D-0125-2020
Classification: Class I
Status: Terminated
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: U.S.A. Nationwide
Recall initiated: 2019-09-06
Classified by FDA Center: 2019-10-03
FDA published: 2019-10-02
Terminated: 2021-02-05
Recalling firm: Darmerica, LLC
Firm location: Casselberry, FL

‹ All recalls