CLASS I Drug recall · Reported 2 Oct 2019 · FDA Enforcement Report
Quinacrine Dihydrochloride 25%), bulk API product recalled by Darmerica
Darmerica is recalling Quinacrine Dihydrochloride 25%), bulk API product, distributed nationwide in the US. The recall was initiated on 6 Sep 2019 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0125-2020
- FDA event ID
- 83734
- Recalling firm
- Darmerica, Casselberry, FL
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 6 Sep 2019
- FDA classified
- 3 Oct 2019
- Reported
- 2 Oct 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
Timeline
| 6 Sep 2019 | Recall initiated by company | |
| 2 Oct 2019 | Published in enforcement report | +26 days |
| 3 Oct 2019 | Classified by FDA | +1 day |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Label Mix-Up: Product labeled as Quinacrine Dihydrochloride; however, after testing, identified as Artemisinin.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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
Where it was distributed
U.S.A. Nationwide
Questions about this recall
Is Quinacrine Dihydrochloride 25%), bulk API product recalled?
Yes. Darmerica recalled Quinacrine Dihydrochloride 25%), bulk API product on 6 Sep 2019. The recall is Class I and its status is Terminated. Recall number D-0125-2020.
Why was it recalled?
Label Mix-Up: Product labeled as Quinacrine Dihydrochloride; however, after testing, identified as Artemisinin.
Which lots are affected?
Lot#: a) DL4654A, Exp. 04/27/21; b) DR4654, Exp. 04/27/21 c) DR4654, Exp. 04/27/21
Where was it sold?
U.S.A. Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.