FDA Recalls Quinacrine Dihydrochloride Bulk API Due to Labeling Error
Darmerica, LLC is recalling 1.8 kilograms of bulk Quinacrine Dihydrochloride API because testing revealed the product was actually Artemisinin.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which indicates a reasonable probability that use of the product will cause serious adverse health consequences or death.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for Quinacrine Dihydrochloride (98.25%), a bulk active pharmaceutical ingredient (API) product manufactured by Darmerica, LLC. The recall involves 1.8 kilograms of the product, which was packaged in 500 g, 50 g, and 25 g containers. The affected lots are DL4654A, DR4654, and DR4654, all with an expiration date of 04/27/21.
The reason for the recall is a label mix-up. Although the product was labeled as Quinacrine Dihydrochloride, subsequent testing identified the substance as Artemisinin. This mislabeling presents a risk because users may administer the wrong medication or compound.
The product was distributed nationwide in the U.S.A. Consumers and healthcare providers who possess this product should stop using it immediately and contact Darmerica, LLC or their healthcare provider for instructions on how to return or dispose of the medication.
The recalled product
- 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
- Manufacturer
- Darmerica, LLC
- Category
- Drug — Bulk API
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot#: a) DL4654A
- Exp. 04/27/21
- b) DR4654
- Exp. 04/27/21 c) DR4654
Distribution
Distributed nationwide across the United States.
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