Why it was recalled
Marketed without an Approved NDA/ANDA; product found to be tainted with sildenafil
Product description
Bull Capsules, 1800 mg/grain, 30 count per tin, Hongkong Jiuyuejiu Biology Technology CO., LTD, BYL Solutions, Inc. dba Nutra Labs, Inc., Palmetto, FL
Lot numbers, UPCs & expiration codes
All lots remaining within expiry.
Where it was sold
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-0414-2018
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Nov 30, 2017
- FDA report date
- Feb 21, 2018
- Quantity
- 329 tins
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- BYL Solutions Inc.
Original FDA data
Every field from FDA enforcement report D-0414-2018, exactly as published.
Show all FDA fields
- City
- Palmetto
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 78666
- Address
- 1301 10th St E Ste A
- Code information
- All lots remaining within expiry.
- Postal code
- 34221-4161
- Report date
- Feb 21, 2018
- Product type
- Drugs
- Recall number
- D-0414-2018
- Classification
- Class III
- Recalling firm
- BYL Solutions Inc.
- Product quantity
- 329 tins
- Termination date
- May 11, 2020
- Reason for recall
- Marketed without an Approved NDA/ANDA; product found to be tainted with sildenafil
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Bull Capsules, 1800 mg/grain, 30 count per tin, Hongkong Jiuyuejiu Biology Technology CO., LTD, BYL Solutions, Inc. dba Nutra Labs, Inc., Palmetto, FL
- Distribution pattern
- Nationwide
- Recall initiation date
- Nov 30, 2017
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Feb 12, 2018