D-0414-2018 Class III Terminated
FDA drug recall D-0414-2018 was initiated by BYL Solutions Inc. on November 30, 2017 and is designated Class III. Reason for recall: Marketed without an Approved NDA/ANDA; product found to be tainted with sildenafil The recall status is terminated (terminated May 11, 2020). Affected quantity: 329 tins.
Recall Details
- Product Type
- Drugs
- Report Date
- February 21, 2018
- Initiation Date
- November 30, 2017
- Termination Date
- May 11, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 329 tins
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
Reason for Recall
Marketed without an Approved NDA/ANDA; product found to be tainted with sildenafil
Distribution Pattern
Nationwide
Code Information
All lots remaining within expiry.