Why it was recalled
Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.
Product description
GERMANY NIUBIAN tablets, 3000mg, 10-count bottle, labeling is in foreign language
Lot numbers, UPCs & expiration codes
All Lots
Where it was sold
NY and NJ through six retail stores named "Asian Food Markets"
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-0556-2018
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Mar 7, 2017
- FDA report date
- Feb 7, 2018
- Quantity
- unknown
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- A&H Focal Inc.
Original FDA data
Every field from FDA enforcement report D-0556-2018, exactly as published.
Show all FDA fields
- City
- Staten Island
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 76644
- Address
- 119 Linwood Ave
- Code information
- All Lots
- Postal code
- 10305-4445
- Report date
- Feb 7, 2018
- Product type
- Drugs
- Recall number
- D-0556-2018
- Classification
- Class I
- Recalling firm
- A&H Focal Inc.
- Product quantity
- unknown
- Termination date
- Jun 14, 2019
- Reason for recall
- Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- GERMANY NIUBIAN tablets, 3000mg, 10-count bottle, labeling is in foreign language
- Distribution pattern
- NY and NJ through six retail stores named "Asian Food Markets"
- Recall initiation date
- Mar 7, 2017
- Initial firm notification
- Press Release
- Center classification date
- Feb 28, 2018