Why it was recalled
Labeling: Wrong Bar Code: There is a potential for some units to be mislabeled with an incorrect barcode on the immediate container that scans as heparin sodium 2000 USP units/1000 mL in 0.9% in sodium chloride injection.
Product description
MAGNESIUM SULFATE IN 5% DEXTROSE INJECTION, USP, 10 mg/mL; 100 mL bag, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-6727-23, UPC (01) 0 030409 672723 1.
Lot numbers, UPCs & expiration codes
Lot: 42-120-JT, Exp 01DEC2015
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-1076-2015
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Mar 6, 2015
- FDA report date
- May 20, 2015
- Quantity
- 181,704 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hospira Inc.
Original FDA data
Every field from FDA enforcement report D-1076-2015, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 70643
- Address
- 275 N Field Dr
- Code information
- Lot: 42-120-JT, Exp 01DEC2015
- Postal code
- 60045-2579
- Report date
- May 20, 2015
- Product type
- Drugs
- Recall number
- D-1076-2015
- Classification
- Class I
- Recalling firm
- Hospira Inc.
- Product quantity
- 181,704 bags
- Termination date
- Oct 19, 2016
- Reason for recall
- Labeling: Wrong Bar Code: There is a potential for some units to be mislabeled with an incorrect barcode on the immediate container that scans as heparin sodium 2000 USP units/1000 mL in 0.9% in sodium chloride injection.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- MAGNESIUM SULFATE IN 5% DEXTROSE INJECTION, USP, 10 mg/mL; 100 mL bag, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-6727-23, UPC (01) 0 030409 672723 1.
- Distribution pattern
- Nationwide
- Recall initiation date
- Mar 6, 2015
- Initial firm notification
- Press Release
- Center classification date
- May 13, 2015