Drug product
Sodium Chloride 0.9% Injection, USP, 1000 mL bags, Rx only, Manufactured by: Fresenius Medical Care North America, Waltham, MA 02451
D-1064-2020
Product summary
- Event
- Event 85228
- Status
- Terminated
- Classification
- Class II
- Quantity
- 32,592 bags
- Official record key
drug-enforcement:D-1064-2020
Official wording
Reason: CGMP Deviation: Chemical indicators were not positioned properly during sterilization process.
Code information: Lot #: 19EG02012, 19EG02019, Exp. Date 05/2020; 19DG02050, Exp. Date 04/2020
Distribution pattern: Product was distributed throughout the United States.
Derived failure modes
-
Manufacturing or process control
CGMP Deviation