Drug product
Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7902-09.
D-0278-2015
Product summary
- Firm
- Hospira Inc.
- Event
- Event 69494
- Status
- Terminated
- Classification
- Class II
- Quantity
- 836,460 bags
- Official record key
drug-enforcement:D-0278-2015
Official wording
Reason: Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.
Code information: Lot # 34-017-JT; Exp. 10/15 Lot # 35-100-JT; Exp. 11/15
Distribution pattern: Nationwide, Puerto Rico, and U.S. Virgin Islands.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility