Recalls / Class III
Class IIID-0727-2016
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.
- Affected lot / code info
- Lot #: 56-853-FW, Exp 01AUG2017
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".
Recalling firm
- Firm
- Hospira Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 275 N Field Dr, N/A, Lake Forest, Illinois 60045-2579
Distribution
- Quantity
- 10,778 bags
- Distribution pattern
- Nationwide and Hong Kong
Timeline
- Recall initiated
- 2016-02-02
- FDA classified
- 2016-02-24
- Posted by FDA
- 2016-03-02
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0727-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.