Why it was recalled
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.
Product description
Burro en Primavera, 2 capsules, UPC 638632431055
Lot numbers, UPCs & expiration codes
All
Where it was sold
USA 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-0370-2021
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Mar 31, 2021
- FDA report date
- May 12, 2021
- Quantity
- 500 boxes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- QMart
Original FDA data
Every field from FDA enforcement report D-0370-2021, exactly as published.
Show all FDA fields
- City
- Elmwood Park
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 87751
- Address
- 495 Mola Blvd
- Code information
- All
- Postal code
- 07407-2041
- Report date
- May 12, 2021
- Product type
- Drugs
- Recall number
- D-0370-2021
- Classification
- Class II
- Recalling firm
- QMart
- Product quantity
- 500 boxes
- Reason for recall
- Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Burro en Primavera, 2 capsules, UPC 638632431055
- Distribution pattern
- USA Nationwide
- Recall initiation date
- Mar 31, 2021
- Initial firm notification
- Press Release
- Center classification date
- May 6, 2021