FDA recall D-0526-2017

Product

TACROLIMUS 0.1% Ointment and TACROLIMUS 0.1%/KETOCONAZOLE 2%, 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-0526-2017