Why it was recalled
Label Mix-Up: Product labeled as Quinacrine Dihydrochloride; however, after testing, identified as Artemisinin.
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
Lot numbers, UPCs & expiration codes
Lot#: a) DL4654A, Exp. 04/27/21; b) DR4654, Exp. 04/27/21 c) DR4654, Exp. 04/27/21
Where it was sold
U.S.A. Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0125-2020
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Sep 6, 2019
- FDA report date
- Oct 2, 2019
- Quantity
- 1.8 kilograms
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Darmerica, LLC
Original FDA data
Every field from FDA enforcement report D-0125-2020, exactly as published.
Show all FDA fields
- City
- Casselberry
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 83734
- Address
- 198 Wilshire Blvd
- Code information
- Lot#: a) DL4654A, Exp. 04/27/21; b) DR4654, Exp. 04/27/21 c) DR4654, Exp. 04/27/21
- Postal code
- 32707-5352
- Report date
- Oct 2, 2019
- Product type
- Drugs
- Recall number
- D-0125-2020
- Classification
- Class I
- Recalling firm
- Darmerica, LLC
- Product quantity
- 1.8 kilograms
- Termination date
- Feb 5, 2021
- Reason for recall
- Label Mix-Up: Product labeled as Quinacrine Dihydrochloride; however, after testing, identified as Artemisinin.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- U.S.A. Nationwide
- Recall initiation date
- Sep 6, 2019
- Initial firm notification
- Letter
- Center classification date
- Oct 3, 2019