FDA recall D-0414-2018

BYL Solutions Inc. · Class III · 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

Reason for recall

Marketed without an Approved NDA/ANDA; product found to be tainted with sildenafil

Distribution

Nationwide

Key facts

Status
Terminated
Initiation date
2017-11-30
Report date
2018-02-21
Termination date
2020-05-11
Voluntary/Mandated
Voluntary: Firm initiated
Location
Palmetto, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0414-2018