Exact FDA event identifier

Event 83734

1 recalled-product record grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: September 06, 2019
Product types: Drug
Classifications: Class I
Statuses: Terminated
Recalling firm wording: Darmerica, LLC

Dossier provenance

Source snapshots represented here

openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 1

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

Recall number: D-0125-2020
Initiated: September 06, 2019
Classification: Class I
Status: Terminated
Recalling firm: Darmerica, LLC
Quantity: 1.8 kilograms

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

Label Mix-Up

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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