Drug product
Sodium Chloride 0.9% Injection, USP, 1000 mL bags, 12 bags per carton, Rx only, Fresenius Medical Care North America, Waltham, MA 02451, NDC # 49230-300-10
D-0777-2023
Product summary
- Event
- Event 92403
- Status
- Terminated
- Classification
- Class II
- Quantity
- 53,424 bags
- Official record key
drug-enforcement:D-0777-2023
Official wording
Reason: Lack of assurance of sterility: The product was potentially exposed to below-recommended storage temperatures, which may cause leaks in the packaging.
Code information: Lot # 23AU05030, Exp 01/13/2024; 23AU05035, Exp 01/15/2024
Distribution pattern: Product was distributed to 32 clinics in SC, NC and VA.
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility