May 2015 FDA Recall Drug by Hospira Inc.
D-1232-2015 - Failed pH Specifications

This Class III drug recall was voluntarily initiated by Hospira Inc. on May 19, 2015 for the product Drug. The FDA reported the reason for recall as failed ph specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1232-2015

Reason for Recall
Failed pH Specifications: 12 month stability testing
Initiated
05-19-2015
Reported
07-15-2015
Quantity
106,900 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71382
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.
U.S. Nationwide, Kuwait, Bahrain and Israel.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-04-2017
Product Description About Product Description
Full technical description of the product.
Magnesium Sulfate Injection, USP, 50%, 20mL, Single dose Fliptop Vial, For IV or IM use, Rx only, Manufactured by Hospira, Inc. 4285 Wesleyan Blvd Rocky Mount, NC 27804 for Hospira, Inc. 275 N Field Drive, Lake Forest, IL 60045. NDC 0409-2168-02

Batch or Lot Expiration Information

Lot# : 39-569-DK, Exp 3/1/2016