Drug 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
D-184-2013
Product summary
- Firm
- Hospira Inc.
- Event
- Event 63522
- Status
- Terminated
- Classification
- Class II
- Quantity
- 11,412 bags
- Official record key
drug-enforcement:D-184-2013
Official wording
Reason: Lack of Assurance of Sterility: There is the potential for the solution to leak from the seal of the fill tube to the bag.
Code information: Lot # 10-199-JT Exp. 10/13
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility