D-1064-2020 Class II Terminated
FDA drug recall D-1064-2020 was initiated by Fresenius Medical Care Holdings, Inc. on March 5, 2020 and is designated Class II. Reason for recall: CGMP Deviation: Chemical indicators were not positioned properly during sterilization process. The recall status is terminated (terminated February 3, 2023). Affected quantity: 32,592 bags.
Recall Details
- Product Type
- Drugs
- Report Date
- March 25, 2020
- Initiation Date
- March 5, 2020
- Termination Date
- February 3, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 32,592 bags
Product Description
Sodium Chloride 0.9% Injection, USP, 1000 mL bags, Rx only, Manufactured by: Fresenius Medical Care North America, Waltham, MA 02451
Reason for Recall
CGMP Deviation: Chemical indicators were not positioned properly during sterilization process.
Distribution Pattern
Product was distributed throughout the United States.
Code Information
Lot #: 19EG02012, 19EG02019, Exp. Date 05/2020; 19DG02050, Exp. Date 04/2020