FDA recall D-0211-2017

Product

Lidocaine HCL/ Sodium Bicarb, 1%/0.5% 0.5 mL SYR PF, packaged in a 3 cc pre-filled syringe, Rx only

Reason for recall

Non-Sterility: failed sterility test result.

Distribution

Two medical facilities in TX

Key facts

Status

Terminated

Initiation date

2016-09-23

Report date

2016-12-28

Termination date

2017-08-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

Dallas, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0211-2017