FDA recall D-0374-2019

PharMEDium Services, LLC. · Class II · drug

Product

0.9% Buffered Lidocaine HCl (buffered in 8.4% Sodium Bicarbonate) a.) 1 mL in 3 mL BD Syringe, 10 per carton, b.) 0.9% Buffered Lidocaine HCl (buffered in 8.4% Sodium Bicarbonate) 5 mL in 5 mL BD Syringe, 10 per carton Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land, TX 77478.

Reason for recall

Subpotent

Distribution

Product was distributed throughout the United States.

Key facts

Status
Terminated
Initiation date
2019-01-02
Report date
2019-01-16
Termination date
2020-05-07
Voluntary/Mandated
Voluntary: Firm initiated
Location
Cleveland, MS, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0374-2019