FDA recall D-0795-2016

Product

Edetate Disodium 2% Ophth Solution, 15mL bottle, Rx only, Walter's Pharmacy, 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9019-47

Reason for recall

Lack of Assurance of Sterility

Distribution

PA

Key facts

Status

Terminated

Initiation date

2016-02-12

Report date

2016-04-06

Termination date

2017-01-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Allentown, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0795-2016