FDA recall D-0789-2016

Walter's Pharmacy · Class II · drug

Product

Rose Bengal 1% Ophth Solution, 5mL bottle, Rx only, Walter's Pharmacy 401 N 17th St., Allentown, PA 610-435-4706

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-0789-2016