D-0125-2020 Class I Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- October 2, 2019
- Initiation Date
- September 6, 2019
- Termination Date
- February 5, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1.8 kilograms
Product Description
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 Pattern
U.S.A. Nationwide
Code Information
Lot#: a) DL4654A, Exp. 04/27/21; b) DR4654, Exp. 04/27/21 c) DR4654, Exp. 04/27/21