March 2016 FDA Recall Drug by Hospira Inc.
D-0865-2016 - Presence of Particulate Matter

This Class I drug recall was voluntarily initiated by Hospira Inc. on March 18, 2016 for the product Drug. The FDA reported the reason for recall as presence of particulate matter. The product was distributed Nationwide and the recall is currently ongoing.

Recall Number: D-0865-2016

Reason for Recall
Presence of Particulate Matter: particulate matter identified as an insect in one vial.
Initiated
03-18-2016
Reported
06-01-2016
Quantity
72,000 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73653
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
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
Product Description About Product Description
Full technical description of the product.
8.4% Sodium Bicarbonate Injection, USP 50mEq (1mEq/mL), 4.2 grams (84 mg/mL), 50 mL, Rx only, Hospira Inc, Lake Forest, IL 60045, NDC 0409-6625-02

Batch or Lot Expiration Information

Lot# 56-148-EV, Exp 8/1/2017