Why it was recalled
Marketed Without an Approved NDA/ANDA: Eugene FDA laboratory analyses determined they contain undeclared sildenafil.
Product description
AFRICAN BLACK ANT, 2800 mg, 6 capsules per box, produced by: Qinghan Hongwei Bioengineering Company, No. 158, Renmin Road, Xining City.
Lot numbers, UPCs & expiration codes
All lots
Where it was sold
To retailers in MD, TX, FL, PA, IL, NJ, IN, LA, WA, ME, SC
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
- D1612-2014
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- May 5, 2014
- FDA report date
- Oct 8, 2014
- Quantity
- 460 boxes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Eugene Oregon, Inc.
Original FDA data
Every field from FDA enforcement report D1612-2014, exactly as published.
Show all FDA fields
- City
- Levittown
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 68218
- Address
- 54 Spinythorn Road
- Code information
- All lots
- Postal code
- 19056
- Report date
- Oct 8, 2014
- Product type
- Drugs
- Recall number
- D1612-2014
- Classification
- Class I
- Recalling firm
- Eugene Oregon, Inc.
- Product quantity
- 460 boxes
- Termination date
- Apr 1, 2015
- Reason for recall
- Marketed Without an Approved NDA/ANDA: Eugene FDA laboratory analyses determined they contain undeclared sildenafil.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- AFRICAN BLACK ANT, 2800 mg, 6 capsules per box, produced by: Qinghan Hongwei Bioengineering Company, No. 158, Renmin Road, Xining City.
- Distribution pattern
- To retailers in MD, TX, FL, PA, IL, NJ, IN, LA, WA, ME, SC
- Recall initiation date
- May 5, 2014
- Initial firm notification
- Letter
- Center classification date
- Sep 29, 2014