Recalls / Class II
Class IID-0490-2025
Product
0.9% Sodium Chloride Injection, USP, Flexible Plastic Container, Rx Only Fresenius Medical Care North America, Waltham, MA 02451, 1-800-323-5188, 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
- 24PU06037, 24PU06038, 24PU06040, 24PU06041, 24PU06042, 24PU06043, 24PU06044, 24PU06045, 24PU0646, 24PU06047, 24PU06048, 24PU06049, 24PU06050, 24PU06052, 24PU06053, 24PU06054 & 24PU06055, Exp Date 11/30/2025; 24SU06001, 24SU06002, 24SU06003, 24SU06004, 24SU06005, 24SU06006, 24SU06007, 24SU06009, 24SU06010, 24SU06011 24SU06012, 24SU06013, 24SU06014, 24SU06015, 24SU06016, 24SU06017, 24SU06018, 24SU06019, 24SU06020, 24SU06021, 24SU06022, 24SU06023, 24SU06024, 24SU06025,24SU06026, 24SU06028,24SU06029, 24SU06030, 24SU06031, 24SU06032, 24SU06033 24SU06034, 24SU06035, 24SU06036, 24SU06037, 24SU06038, 24SU06039, 24SU06040, 24SU06041, 24SU06042, 24SU06043, 24SU06044, 24SU06045, 24SU06046, 24SU06047, 24SU06048, 24SU06049, 24SU06050, 24SU06051, 24SU06052, 24SU06053, 24SU06054, 24SU06055, 24SU06056, & 24SU06057, Exp Date 12/31/25 25AU06001, 25AU06002, 25AU06003. 25AU06004, 25AU06005, 25AU06006, 25AU06007, 25AU06008, 25AU06009, 25AU06010, 25AU06011, 25AU06013, 25AU06017, 25AU06020 25AU06021, 25AU06022, 25AU06027, 25AU06028, 25AU06029, 25AU06030, 25AU06031 25AU06032, 25AU06034, 25AU06035, 25AU06036, 25AU06037, 25AU06038, 25AU06039 25AU06040, 25AU06041, 25AU06042, 25AU06043, 25AU06044, 25AU06045, 25AU06046 25AU06047, 25AU06048, 25AU06049, 25AU06050, 25AU06051, 25AU06052, 25AU06053 & 25AU06056, Exp Date 1/31/26 25BU06001, 25BU06003, 25BU06004, 25BU06005, 25BU06006, 25BU06007, 25BU06008 25BU06009, 25BU06010, 25BU06011, 25BU06018, 25BU06020, 25BU06023, 25BU06024 25BU06026, 25BU06027, 25BU06028, 25BU06030, 25BU06031, 25BU06032, 25BU06033 25BU06034, 25BU06035, 25BU06036, 25BU06037, 25BU06038, 25BU06039, 25BU06040 25BU06041, 25BU06042, 25BU06043, 25BU06044, 25BU06045, 25BU06046 25BU06047, 25BU06049, 25BU06050, 25BU06051, 25BU06053 & 25BU06054, Exp Date 02/28/26 25CU06002, 25CU06003, 25CU06004, 25CU06005, 25CU06006, 25CU06007, 25CU06008 25CU06012, 25CU06013, 25CU06015, 25CU06016, 25CU06020, 25CU06021, 25CU06022 25CU06023, 25CU06024, 25CU06026, 25CU06028, 25CU06030, 25CU06032, 25CU06035 25CU06039, Exp Date 03/31/2026
Why it was recalled
Lack of Assurance of Sterility
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 920, Waltham, Massachusetts 02451-1521
Distribution
- Quantity
- 3,651,468 containers
- Distribution pattern
- Nationwide.
Timeline
- Recall initiated
- 2025-05-27
- FDA classified
- 2025-06-23
- Posted by FDA
- 2025-07-02
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0490-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.