Recalls / Class II
Class IID-0777-2023
Product
Sodium Chloride 0.9% Injection, USP, 1000 mL bags, 12 bags per carton, 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 # 23AU05030, Exp 01/13/2024; 23AU05035, Exp 01/15/2024
Why it was recalled
Lack of assurance of sterility: The product was potentially exposed to below-recommended storage temperatures, which may cause leaks in the packaging.
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
- 53,424 bags
- Distribution pattern
- Product was distributed to 32 clinics in SC, NC and VA.
Timeline
- Recall initiated
- 2023-05-23
- FDA classified
- 2023-06-01
- Posted by FDA
- 2023-06-07
- Terminated
- 2024-05-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0777-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.