FDA recall D-1076-2018

Huijing (Shanghai) Bio-tech Co., Ltd. · Class III · drug

Product

Acne Treatment Pads (2% salicylic acid), packaged in a 50-count jar, OTC, Distributed by: Greenbrier International, Inc. 500 Volvo Parkway, Chesapeake, VA 23320, NDC 71537-001-02

Reason for recall

Subpotent drug: The product active ingredient level not matching the exact levels indicated on the packaging label.

Distribution

Product was distributed to one distributor in VA

Key facts

Status
Terminated
Initiation date
2018-08-03
Report date
2018-08-22
Termination date
2018-12-19
Voluntary/Mandated
Voluntary: Firm initiated
Location
Shanghai, China

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1076-2018