Injectable Sodium Chloride Recalled Due to Sterility Assurance Defect
Fresenius Medical Care is recalling 3,651,468 containers of 0.9% Sodium Chloride Injection nationwide due to sterility assurance defects. Healthcare facilities should immediately discontinue use of affected batches.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall involving lack of sterility assurance on an intravenous injectable. The source does not report illnesses or infections, and the hazard is potential rather than confirmed. Per the rubric, theoretical hazards without reported incidents score at most 3 (High).
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling 3,651,468 containers of 0.9% Sodium Chloride Injection, USP (intravenous saline solution) distributed nationwide. This product is used in hospitals and clinical settings for intravenous therapy and medical procedures.
The recall was initiated because Fresenius cannot assure that all containers meet required sterility standards. Lack of sterility in injectable medications poses a potential risk of contamination and infection to patients.
Healthcare facilities and hospitals that have received affected batches should immediately discontinue use. Contact Fresenius Medical Care at 1-800-323-5188 or the FDA for instructions on product return or destruction. The recall includes multiple lot codes with expiration dates ranging from November 2025 through March 2026.
The recalled product
- Product
- SODIUM CHLORIDE (SODIUM CHLORIDE)
- Brand
- SODIUM CHLORIDE
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Category
- Drug — Intravenous Solution
- Hazard
- sterility-defect
- infection-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
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