FDA recall D-1454-2015

Product

Clotrimazole 2% Otic Suspension, ml, Sterile, Room Temperature, Shake Well, The Compounding Pharmacy of America, Knoxville, TN

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2015-06-02

Report date

2015-09-23

Termination date

2016-02-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Knoxville, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1454-2015