December 15, 2016
More than 287,000 2-mL single-dose ampules of 5% Lidocaine HCL and 7.5% Dextrose Injection, USP, have been recalled in the United States and in Puerto Rico.
Manufacturer Hospira, Inc, voluntarily initiated the ongoing Class III recall back in June due to failed stability specifications. As stated in the latest US Food and Drug Administration Enforcement Report, “The recalled lots did not meet the specification for color and pH throughout shelf life.”
The code information for the affected product is as follows:
- Lot # 34-547-DK, 34-548-DK, Exp. 10/16
- Lot # 39-372-DK, Exp. 03/17
The report adds that the lot number “may be followed by numbers from 01 to 99.”
The recalled prescription product, which is indicated for the production of spinal anesthesia, is packaged in a 5-count box.--Meredith Edwards White
Enforcement Report. US Food and Drug Administration Website. http://www.accessdata.fda.gov/scripts/ires/index.cfm. Published December 14, 2016. Accessed December 15, 2016.