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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Drug
Medications & Supplements/Prescription Drugs

Darmerica, LLC: Quinacrine Dihydrochloride Recalled Due to Label Mix-Up with Artemisinin

Agency Publication Date: September 24, 2019
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Summary

Darmerica, LLC has recalled 1.8 kilograms (approximately 2 units) of Quinacrine Dihydrochloride (98.25%) bulk API product because of a label mix-up. Testing revealed that the product labeled as Quinacrine Dihydrochloride is actually Artemisinin. Consumers who may have received this product should contact their healthcare provider or pharmacist immediately, as the product is not the medication indicated on the label.

Risk

The product contains a different active ingredient (Artemisinin) than what is stated on the label (Quinacrine Dihydrochloride). This mix-up could lead to patients receiving the wrong medication, resulting in untreated medical conditions or unexpected side effects from the substituted ingredient.

What You Should Do

  1. Immediately check your inventory for Quinacrine Dihydrochloride (98.25%) bulk API product in 500 g, 50 g, or 25 g containers.
  2. Identify affected products by looking for the following NDC numbers and Lot details: NDC# 71052-530-05 (Lot DL4654A, Exp. 04/27/21), NDC# 71052-530-55 (Lot DR4654, Exp. 04/27/21), and NDC# 71052-530-25 (Lot DR4654, Exp. 04/27/21).
  3. Stop using the product immediately if it matches the identified lot numbers and expiration dates.
  4. Contact your healthcare provider or pharmacist for guidance regarding any medication prepared with this bulk ingredient.
  5. Return any unused product to the place of purchase for a refund and contact Darmerica, LLC for further instructions.
  6. For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Quinacrine Dihydrochloride (98.25%) bulk API product (500 g)
Model:
NDC# 71052-530-05
Lot Numbers:
DL4654A (Exp. 04/27/21)
Date Ranges: April 27, 2021
Product: Quinacrine Dihydrochloride (98.25%) bulk API product (50 g)
Model:
NDC# 71052-530-55
Lot Numbers:
DR4654 (Exp. 04/27/21)
Date Ranges: April 27, 2021
Product: Quinacrine Dihydrochloride (98.25%) bulk API product (25 g)
Model:
NDC# 71052-530-25
Lot Numbers:
DR4654 (Exp. 04/27/21)
Date Ranges: April 27, 2021

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 83734
Status: Resolved
Manufacturer: Darmerica, LLC
Sold By: Darmerica LLC
Manufactured In: United States
Units Affected: 1.8 kilograms
Distributed To: Nationwide
Agency Last Updated: October 3, 2019

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.