Why it was recalled
Labeling: Incorrect Barcode: Primary bag labeling may be mislabeled with the wrong barcode which scans in as heparin sodium.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot: 53-113-JT, Exp 1NOV2016
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-0668-2016
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Jan 5, 2016
- FDA report date
- Feb 24, 2016
- Quantity
- 213,600 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hospira Inc.
Original FDA data
Every field from FDA enforcement report D-0668-2016, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 72996
- Address
- 275 N Field Dr
- Code information
- Lot: 53-113-JT, Exp 1NOV2016
- Postal code
- 60045-2579
- Report date
- Feb 24, 2016
- Product type
- Drugs
- Recall number
- D-0668-2016
- Classification
- Class I
- Recalling firm
- Hospira Inc.
- Product quantity
- 213,600 bags
- Termination date
- Sep 28, 2017
- Reason for recall
- Labeling: Incorrect Barcode: Primary bag labeling may be mislabeled with the wrong barcode which scans in as heparin sodium.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide
- Recall initiation date
- Jan 5, 2016
- Initial firm notification
- Press Release
- Center classification date
- Feb 16, 2016