Recalls / Class II
Class IID-1036-2014
Product
Heparin Sodium 2000 USP Heparin Units per 1000 mL (2 USP Heparin Units/mL) in 0.9% Sodium Chloride Injection, Rx only. Hospira, Lake Forest, IL 60045. NDC 0409-7620-59.
- Brand name
- Heparin Sodium
- Generic name
- Heparin Sodium
- Active ingredient
- Heparin Sodium
- Route
- Intravenous
- NDCs
- 0409-1005, 0409-7620, 0409-2222
- FDA application
- NDA018916
- Affected lot / code info
- Lot #: 26-125-JT, Exp: 8/14
Why it was recalled
Lack of Assurance of Sterility; potential leakage from administrative port.
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
- 27780 bags
- Distribution pattern
- Nationwide including Puerto Rico
Timeline
- Recall initiated
- 2014-01-09
- FDA classified
- 2014-01-24
- Posted by FDA
- 2014-02-05
- Terminated
- 2015-05-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1036-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.