FDA recall D-0010-2017

Product

Atropine Sulfate 0.01% in 0.9% Sodium Chloride (Ophthalmic Solution) 10 mL Total Volume in a 15 mL Dropper Bottle, Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-011-39

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-0010-2017