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Recall Observatory FDA recall evidence

Drug 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

D-0169-2017

June 29, 2016

Class III

Product summary

Firm
Hospira Inc.
Event
Event 74720
Status
Terminated
Classification
Class III
Quantity
287,200 2 mL ampules
Official record key
drug-enforcement:D-0169-2017

Official wording

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

Code information: Lot # 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

Distribution pattern: US and Puerto Rico

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Failed Stability Specifications