Recalls / Class II
Class IID-0075-2023
Product
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
- Brand name
- Sodium Chloride
- Generic name
- Sodium Chloride
- Active ingredient
- Sodium Chloride
- Route
- Intravenous
- NDC
- 49230-300
- FDA application
- ANDA078177
- Affected lot / code info
- Lot # 22HU05062, 22HU06059, 22HU05035, EXP 06/30/2023; 22JU05001, EXP 07/31/2023
Why it was recalled
Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.
Recalling firm
- Firm
- Fresenius Medical Care Holdings, Inc.
- Manufacturer
- Fresenius Medical Care Renal Therapies Group, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 920 Winter St Bld 950, N/A, Waltham, Massachusetts 02451-1521
Distribution
- Quantity
- 4,097 cases/12 bags per case
- Distribution pattern
- Product was distributed Nationwide in the USA.
Timeline
- Recall initiated
- 2022-11-22
- FDA classified
- 2022-12-02
- Posted by FDA
- 2022-12-14
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0075-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.