April 2012 FDA Recall Magnesium Sulfate In Water by Hospira, Inc. (D-1390-2012 - Superpotent (Single Ingredient) Drug)
This Class III drug recall was voluntarily initiated by Hospira, Inc. on April 5, 2012 for the product Magnesium Sulfate In Water. The FDA reported the reason for recall as superpotent (single ingredient) drug. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1390-2012
Superpotent (Single Ingredient) Drug: Above specification assay results for percentage of magnesium sulfate.
04-05-2012
06-27-2012
164,568 containers
Recall Profile & Regulatory Data
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.
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
08-08-2013
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Magnesium Sulfate in Water for Injection, 40 mg/mL (0.325 mEq Mg++/mL), 2 g total, 50 mL Flexible Container, Rx only, Hospira, Inc., Lake Forest, IL 60045; NDC 0409-6729-24.
Batch or Lot Expiration Information
Lot# : 04510KL*, Exp 01OCT2012; *lot number may have 01 or 02 following it
