Drug product
0.9% Sodium Chloride Injection, USP, 100 mL bag, Rx Only ,Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7984-37
D-0884-2018
Product summary
- Firm
- ICU Medical Inc
- Event
- Event 80213
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1247200 bags
- Official record key
drug-enforcement:D-0884-2018
Official wording
Reason: Lack of assurance of sterility: Bags have potential to leak.
Code information: Lot #: 85-021-JT, Exp 01/012020; 86-001-JT, Exp 02/01/2020
Distribution pattern: Nationwide and Canada
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility