Drug product
0.9% Sodium Chloride Injection, USP, 1000 mL, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 49230-0300-10.
D-0827-2018
Product summary
- Event
- Event 79501
- Status
- Terminated
- Classification
- Class II
- Quantity
- 25,356 1 liter bags
- Official record key
drug-enforcement:D-0827-2018
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot # 17LU05005; Exp. 09/18 Part Number 060-10109
Distribution pattern: Product was distributed throughout the United States.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility