FDA recall D-0549-2016

Product

Gentamicin 14.4 mg/sodium chloride 0.9% 30 mL Prefilled syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045

Reason for recall

Lack of Assurance of Sterility

Distribution

Texas

Key facts

Status

Terminated

Initiation date

2015-11-10

Report date

2016-01-06

Termination date

2017-10-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

San Antonio, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0549-2016