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Class III: unlikely to cause harmTerminated

Hospira Magnesium Sulfate in Water for Injection Recall

Magnesium Sulfate in Water for Injection, 40 mg/mL (0

Hospira, Inc. · Lake Forest, IL

Risk level
Class III
Reported by FDA
Jun 27, 2012
Recall ID
D-1390-2012
Check your lot numberHow we source this data

Summary

Hospira recalled Magnesium Sulfate in Water for Injection starting Apr 5, 2012. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-1390-2012 on Jun 27, 2012. Reason: Superpotent (Single Ingredient) Drug: Above specification assay results for percentage of magnesium sulfate. Status: Terminated.

Why it was recalled

Superpotent (Single Ingredient) Drug: Above specification assay results for percentage of magnesium sulfate.

Product description

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.

Lot numbers, UPCs & expiration codes

Lot #: 04510KL*, Exp 01OCT2012; *lot number may have 01 or 02 following it

Where it was sold

Nationwide

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-1390-2012
Classification
Class III
Status
Terminated
Recall initiated
Apr 5, 2012
FDA report date
Jun 27, 2012
Quantity
164,568 containers
Recall type
Voluntary: Firm initiated
Recalling firm
Hospira, Inc.

Original FDA data

Every field from FDA enforcement report D-1390-2012, exactly as published.

Show all FDA fields
City
Lake Forest
State
IL
Status
Terminated
Country
United States
Event ID
62053
Address
600 N Field Dr Bldg J45
Code information
Lot #: 04510KL*, Exp 01OCT2012; *lot number may have 01 or 02 following it
Postal code
60045
Report date
Jun 27, 2012
Product type
Drugs
Recall number
D-1390-2012
Classification
Class III
Recalling firm
Hospira, Inc.
Product quantity
164,568 containers
Termination date
Aug 8, 2013
Reason for recall
Superpotent (Single Ingredient) Drug: Above specification assay results for percentage of magnesium sulfate.
Voluntary / mandated
Voluntary: Firm initiated
Product description
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.
Distribution pattern
Nationwide
Recall initiation date
Apr 5, 2012
Initial firm notification
Letter
Center classification date
Jun 20, 2012

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1390-2012, published Jun 27, 2012. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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