February 2016 FDA Recall Drug by Hospira Inc.
D-0727-2016 - Labeling

This Class III drug recall was voluntarily initiated by Hospira Inc. on February 2, 2016 for the product Drug. The FDA reported the reason for recall as labeling. The product was distributed Nationwide and the recall is currently ongoing.

Recall Number: D-0727-2016

Reason for Recall
Labeling: Incorrect or Missing Lot and/or Exp Date: Confirmed customer report of an incorrect expiration date printed on the primary container labeled "01AUG1017" rather than "01AUG2017".
Initiated
02-02-2016
Reported
03-02-2016
Quantity
10,778 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73313
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.
Ongoing
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.
Nationwide and Hong Kong
Product Description About Product Description
Full technical description of the product.
Normosol-M and 5% Dextrose (multiple electrolytes and 5% dextrose) Injection Type 1, USP, 1000 mL Single-Dose Container bag, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7965-09, Barcode (01) 0 030409 796509 0.

Batch or Lot Expiration Information

Lot# : 56-853-FW, Exp 01AUG2017