June 2016 FDA Recall Drug by Hospira Inc.
D-0169-2017 - Failed Stability Specifications

This Class III drug recall was voluntarily initiated by Hospira Inc. on June 29, 2016 for the product Drug. The FDA reported the reason for recall as failed stability specifications. The product was distributed in US and Puerto Rico and the recall is currently terminated.

Recall Number: D-0169-2017

Reason for Recall
Failed Stability Specifications: The recalled lots did not meet the specification for color and pH throughout shelf life.
Initiated
06-29-2016
Reported
12-14-2016
Quantity
287,200 2 mL ampules

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74720
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Hospira Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
US and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-20-2019
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration 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