Recalls / Class II
Class IID-184-2013
Product
HEXTEND 6% Hetastarch in Lactated Electrolyte Injection, 500 mL, Rx only , MANUFACTURED AND DISTRIBUTED BY HOSPIRA, INC., LAKE FOREST, IL 60045, NDC 0409-1555-54
- Brand name
- Hextend
- Generic name
- Hetastarch
- Active ingredient
- Hetastarch
- Route
- Intravenous
- NDC
- 0409-1555
- FDA application
- BN200952
- Affected lot / code info
- Lot # 10-199-JT Exp. 10/13
Why it was recalled
Lack of Assurance of Sterility: There is the potential for the solution to leak from the seal of the fill tube to the bag.
Recalling firm
- Firm
- Hospira Inc.
- Manufacturer
- Hospira, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 275 N Field Dr, N/A, Lake Forest, Illinois 60045-2579
Distribution
- Quantity
- 11,412 bags
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2012-10-22
- FDA classified
- 2013-03-05
- Posted by FDA
- 2013-03-13
- Terminated
- 2015-03-31
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-184-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.