Why it was recalled
Labeling: Incorrect or Missing Lot and/or Exp Date: Confirmed customer report of an incorrect expiration date printed on the primary container labeled "01AUG1017" rather than "01AUG2017".
Product description
Normosol-M and 5% Dextrose (multiple electrolytes and 5% dextrose) Injection Type 1, USP, 1000 mL Single-Dose Container bag, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7965-09, Barcode (01) 0 030409 796509 0.
Lot numbers, UPCs & expiration codes
Lot #: 56-853-FW, Exp 01AUG2017
Where it was sold
Nationwide and Hong Kong
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-0727-2016
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- Feb 2, 2016
- FDA report date
- Mar 2, 2016
- Quantity
- 10,778 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hospira Inc.
Original FDA data
Every field from FDA enforcement report D-0727-2016, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Ongoing
- Country
- United States
- Event ID
- 73313
- Address
- 275 N Field Dr
- Code information
- Lot #: 56-853-FW, Exp 01AUG2017
- Postal code
- 60045-2579
- Report date
- Mar 2, 2016
- Product type
- Drugs
- Recall number
- D-0727-2016
- Classification
- Class III
- Recalling firm
- Hospira Inc.
- Product quantity
- 10,778 bags
- Reason for recall
- Labeling: Incorrect or Missing Lot and/or Exp Date: Confirmed customer report of an incorrect expiration date printed on the primary container labeled "01AUG1017" rather than "01AUG2017".
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Normosol-M and 5% Dextrose (multiple electrolytes and 5% dextrose) Injection Type 1, USP, 1000 mL Single-Dose Container bag, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7965-09, Barcode (01) 0 030409 796509 0.
- Distribution pattern
- Nationwide and Hong Kong
- Recall initiation date
- Feb 2, 2016
- Initial firm notification
- Letter
- Center classification date
- Feb 24, 2016