Recalls / Class II
Class IID-0215-2019
Product
5% Dextrose Injection, USP, Rx Only, a) 25 mL NDC 0409-7923-20; b) 250 mL NDC 0409-7922-02, Hospira, Inc. Lake Forest, IL 60045
- Affected lot / code info
- Lots: a) 84-017-JT Exp. December 01, 2019; b) 84-012-JT Exp. June 01, 2019
Why it was recalled
Lack of Assurance of Sterility; bags have the potential to leak
Recalling firm
- Firm
- ICU Medical Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 600 N FIELD DRIVE, LAKE FOREST, Illinois 60045
Distribution
- Quantity
- 372,912 bags
- Distribution pattern
- Nationwide.
Timeline
- Recall initiated
- 2018-10-08
- FDA classified
- 2018-11-02
- Posted by FDA
- 2018-11-14
- Terminated
- 2021-03-08
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0215-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.