Drug product
Bull Capsules, 1800 mg/grain, 30 count per tin, Hongkong Jiuyuejiu Biology Technology CO., LTD, BYL Solutions, Inc. dba Nutra Labs, Inc., Palmetto, FL
D-0414-2018
Product summary
- Event
- Event 78666
- Status
- Terminated
- Classification
- Class III
- Quantity
- 329 tins
- Official record key
drug-enforcement:D-0414-2018
Official wording
Reason: Marketed without an Approved NDA/ANDA; product found to be tainted with sildenafil
Code information: All lots remaining within expiry.
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Marketed without an Approved NDA/ANDA; product found to be tainted with sildenafil