FDA recall D-0169-2017

Product

5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 mL Single-dose ampule, 5 count box, Rx Only, For Spinal Anesthesia Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4712-01

Reason for recall

Failed Stability Specifications: The recalled lots did not meet the specification for color and pH throughout shelf life.

Distribution

US and Puerto Rico

Key facts

Status

Terminated

Initiation date

2016-06-29

Report date

2016-12-14

Termination date

2019-11-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0169-2017