FDA recall D-0525-2017

Product

KETOCONAZOLE 2%/HYDROCORTISONE 1.5% CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676.

Reason for recall

Lack of Assurance of Sterility: There are also CGMP Deviations.

Distribution

Nationwide within the United States

Key facts

Status

Terminated

Initiation date

2017-02-10

Report date

2017-03-22

Termination date

2017-05-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

San Diego, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0525-2017