Recalls / Class II
Class IID-0417-2015
Product
5% DEXTROSE Injection, USP, 250 mL ADD-Vantage Unit bag (NDC 0409-7100-02), UPC (01)0030404097100026; packaged in 24 bags per case pack (NDC 0409-7100-02), UPC (01)30304097100027(30)01, Rx ONLY, Hospira, Inc., Lake Forest, IL 60045.
- Brand name
- Dextrose
- Generic name
- Dextrose Monohydrate
- Active ingredient
- Dextrose Monohydrate
- Route
- Intravenous
- NDC
- 0409-7100
- FDA application
- NDA019466
- Affected lot / code info
- Lot: 37-042-JT, Exp 1JAN2016
Why it was recalled
Lack of Assurance of Sterility: there is a potential for solution to leak at the administrative port of the primary container.
Recalling firm
- Firm
- Hospira Inc.
- Manufacturer
- Hospira, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 275 N Field Dr, Lake Forest, Illinois 60045-2579
Distribution
- Quantity
- 94,440 bags
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-03-05
- FDA classified
- 2015-03-17
- Posted by FDA
- 2015-03-25
- Terminated
- 2016-12-09
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0417-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.