RecallRadar

FDA Drug recall D-0169-2017

5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 mL Single-dose ampule, 5 count box, Rx Only, For Spinal Anesthesia Only, Manufactured…

On 2016-12-14 the FDA classified a Class III recall of 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, citing failed Stability Specifications: The recalled lots did not meet the specification for color and pH throughout shelf life.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0169-2017
ClassificationClass III
Statusterminated
Initiated2016-06-29
Published2016-12-14
Last updated2026-09-13 11:51 UTC
CompanyHospira
DistributionPR

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

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

Identifiers

code_infoLot # 34-547-DK, 34-548-DK, Exp. 10/16, Lot # 39-372-DK, Exp. 03/17 Lot Number may be followed by numbers from 01 to 99

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0169-2017%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.