January 2016 FDA Recall Magnesium Sulfate In Water by Hospira Inc.
D-0668-2016 - Labeling
This Class I drug recall was voluntarily initiated by Hospira Inc. on January 5, 2016 for the product Magnesium Sulfate In Water. The FDA reported the reason for recall as labeling. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0668-2016
Labeling: Incorrect Barcode: Primary bag labeling may be mislabeled with the wrong barcode which scans in as heparin sodium.
01-05-2016
02-24-2016
213,600 bags
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
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.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
09-28-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Magnesium Sulfate in Water for Injection, (0.325 mEq Mg++/mL) 40 mg/mL, 2 g Total, 50 mL Single-Dose Container bag, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-6729-24.
Batch or Lot Expiration Information
Lot# Lot: 53-113-JT, Exp 1NOV2016
