Recalls / Class II
Class IID-1425-2014
Product
Heparin Sodium in 5% Dextrose Injection, Heparin, 25,000 USP Heparin Units/250 mL (100 USP Heparin Units/mL), 250 mL, Single-Dose Container, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-7793-62
- Brand name
- Heparin Sodium And Dextrose
- Generic name
- Heparin Sodium
- Active ingredient
- Heparin Sodium
- Route
- Intravenous
- NDCs
- 0409-4520, 0409-7793, 0409-7794
- FDA application
- NDA019339
- Affected lot / code info
- Lot # 34-811-KL, 36-106-KL, 36-114-KL; Exp. 12/15; 36-101-KL, Exp. 12/15; 37-202-KL, Exp. 1/16; 38-302-KL, Exp. 2/16; 38-305-KL, Exp. 2/16
Why it was recalled
Lack of Assurance of Sterility: Confirmed consumer report of fluid leaking from primary container of bag.
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
- 142,152 bags
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-06-06
- FDA classified
- 2014-07-09
- Posted by FDA
- 2014-07-16
- Terminated
- 2015-04-03
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1425-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.