FDA recall D-0013-2017

Product

Cyclopentolate HCl 1% - Tropicamide 1% - PHENYLephrine HCl 2.5% in Sterile Water for Injection (Ophthalmic Solution), in a) 1 mL Total Volume (NDC 70360-017-38) and b) 10 mL Total Volume (NDC 70360-017-39) in a 15 mL Dropper Bottle, Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-017-38

Reason for recall

Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2016-09-20

Report date

2016-10-19

Termination date

2017-05-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

San Jose, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0013-2017