June 2012 FDA Recall Drug by Hospira, Inc.
D-215-2013 - CGMP Deviations

This Class III drug recall was voluntarily initiated by Hospira, Inc. on June 21, 2012 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed in NC and the recall is currently terminated.

Recall Number: D-215-2013

Reason for Recall
CGMP Deviations: Shipment of product not approved for release.
Initiated
06-21-2012
Reported
04-03-2013
Quantity
1,296 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
63242
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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-28-2013
Product Description About Product Description
Full technical description of the product.
Lactated Ringer's Injection, USP, 1000 mL, Rx only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7953-09

Batch or Lot Expiration Information

Lot# Lot 16-836-FW, Exp 04/14