Recalls / Class II
Class IID-0015-2023
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 # 22EU05043, EXP 5/21/2023; 22HU05018, EXP 6/9/2023; 22HU05019, EXP 6/10/2023; 22HU05025, 22HU05026, EXP 6/12/2023; 22HU05049, EXP 6/22/2023; 22HU05053, EXP 6/24/2023; 22HU05054, 22HU05055, EXP 6/25/2023; 22HU06027, EXP 6/11/2023; 22HU06049, EXP 6/23/2023; 22HU06055, EXP 6/24/2023; 22HU06056, EXP 6/25/2023; 22JU05008, EXP 7/4/2023; 22KU06036, EXP 8/19/2023; 22JU06023, EXP 7/8/2023
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
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 920 Winter St Bld 950, N/A, Waltham, Massachusetts 02451-1521
Distribution
- Quantity
- 16,006 cases of twelve bags each
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2022-10-11
- FDA classified
- 2022-10-20
- Posted by FDA
- 2022-10-26
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0015-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.