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
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
Label Mix-Up