FDA recall D-1418-2015

Oasis Medical, Inc. · Class III · drug

Product

ImproVue Ophthalmic Lubricant Drops (1.7% Hypromellose), 1 Single Use Syringe, 0.07 fl oz (2mL), 1 Single Use Applicator Tip per carton, Manufactured for OCULUS SURGICAL, Port St. Lucie, FL 34986, NDC 62144-5510-05

Reason for recall

Falied pH specification

Distribution

Key facts

Status: Terminated
Initiation date: 2015-08-31
Report date: 2015-09-16
Termination date: 2015-12-18
Voluntary/Mandated: Voluntary: Firm initiated
Location: Glendora, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1418-2015