D-0075-2023 Class II Ongoing
FDA drug recall D-0075-2023 was initiated by Fresenius Medical Care Holdings, Inc. on Nov 22, 2022 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution. The recall status is ongoing. Affected quantity: 4,097 cases/12 bags per case.
Recall Details
- Product Type
- Drugs
- Report Date
- Dec 14, 2022
- Initiation Date
- Nov 22, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,097 cases/12 bags per case
Product Description
0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg, WATER FOR INJECTION, USP - qs, 1000mL Bag, 12 PK, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 49230-300-10
Reason for Recall
Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.
Distribution Pattern
Product was distributed Nationwide in the USA.
Code Information
Lot # 22HU05062, 22HU06059, 22HU05035, EXP 06/30/2023; 22JU05001, EXP 07/31/2023
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0075-2023
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026