Drug product
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.
D-0727-2016
Product summary
- Firm
- Hospira Inc.
- Event
- Event 73313
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 10,778 bags
- Official record key
drug-enforcement:D-0727-2016
Official wording
Reason: 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".
Code information: Lot #: 56-853-FW, Exp 01AUG2017
Distribution pattern: Nationwide and Hong Kong
Derived failure modes
-
Labeling or packaging
Labeling: Incorrect or Missing