Sodium Chloride Injection Recalled Due to Storage Temperature Exposure Risk
Fresenius Medical Care is recalling Sodium Chloride 0.9% Injection due to potential storage temperature exposure that may compromise sterility. The affected product includes 53,424 bags distributed to clinics in South Carolina, North Carolina, and Virginia.
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 of a sterile injectable with potential compromised sterility due to storage temperature exposure. No illnesses or injuries reported. Meets Score 3 criteria: risk-of-harm product where injury has not yet been reported.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling Sodium Chloride 0.9% Injection, USP in 1000 mL bags. The recall affects 53,424 bags distributed to 32 clinics located in South Carolina, North Carolina, and Virginia. The affected lots are 23AU05030 (expiration 01/13/2024) and 23AU05035 (expiration 01/15/2024).
The product was potentially exposed to below-recommended storage temperatures, which may cause leaks in the packaging. This exposure creates a potential lack of assurance of product sterility.
Patients who may have received this product should consult their healthcare provider. Healthcare facilities should stop using the affected product immediately and contact Fresenius Medical Care Holdings, Inc. for further instructions.
The recalled product
- Product
- SODIUM CHLORIDE (SODIUM CHLORIDE)
- Brand
- SODIUM CHLORIDE
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Category
- Drug — Sterile Injectable
- Hazard
- sterility-compromise
- contamination-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 (4)
- Lot # 23AU05030
- Exp 01/13/2024
- 23AU05035
- Exp 01/15/2024
Distribution
Distributed in 3 states:
- NC
- SC
- VA
Related recalls
Same brand · SODIUM CHLORIDE
- HighInjectable Sodium Chloride Ampules Recalled Over Sterility Assurance Concerns
FDA (Drugs) · 2026-04-22
- HighInjectable Sodium Chloride Recalled Due to Sterility Assurance Issue
FDA (Drugs) · 2026-04-15
- HighInjectable Sodium Chloride Recall Due to Sterility Assurance Issue
FDA (Drugs) · 2026-04-15
- HighSodium chloride intravenous injection recalled for lack of sterility assurance
FDA (Drugs) · 2026-04-15
- HighSodium Chloride IV Injection Recall for Sterility Assurance Concerns
FDA (Drugs) · 2026-04-15
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- ModerateFDA Recalls Pred Mild Ophthalmic Suspension Due to Failed Stability Specifications
FDA (Drugs) · 2026-06-03
- ModerateNicotine Transdermal System Patches Recalled for Oxidative Impurity Specification Failure
FDA (Drugs) · 2026-06-03
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27
- LowPrimidone Tablets Recalled for Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27