FDA recall D-0918-2018

Product

Buffered Lidocaine 1% with Sodium Bicarbonate Injection for Local Anesthetic Use (Concentration=10 mg/mL) 0.25 mL Total Volume, Rx only , SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205 877-550-5059

Reason for recall

Subpotent Drug: Stability data does not support the current expiration dating of 55 days after compounding.

Distribution

United States

Key facts

Status

Terminated

Initiation date

2018-06-29

Report date

2018-07-18

Termination date

2019-05-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Little Rock, AR, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0918-2018