FDA recall D-1026-2016

Product

CLOTRIMAZOLE 1%/ BETAMETHASONE DIPROPIONATE 0.05% OTIC SOLUTION, 15mL dropper, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

Reason for recall

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

Distribution

NV

Key facts

Status

Terminated

Initiation date

2016-05-17

Report date

2016-06-15

Termination date

2017-01-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Las Vegas, NV, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1026-2016