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