Sodium Chloride Injection Recalled for Potential Sterility Compromise
Nephron Sterile Compounding Center is recalling Sodium Chloride Injection 9% due to potential leakage at the IV bottle port, which could compromise sterility. Affected lots were distributed nationwide.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 with no reported illnesses or injuries. The potential for sterility compromise in an intravenous product is a significant risk-of-harm scenario where injury has not yet been reported.
Plain-English summary
Nephron Sterile Compounding Center LLC is recalling Sodium Chloride Injection 9%, USP, 500 mL, Single-Dose IV Bottles, a prescription sterile solution. The recall affects 4,190 bottles distributed nationwide.
The recall is due to a potential for leakage at the IV bottle port, which could compromise the sterility assurance of the product. Sodium Chloride Injection is intended for intravenous administration, and loss of sterility assurance poses a potential safety risk.
The recall includes Lot # NA4008B (expiration date 03/03/2025), Lot # NA4005B (expiration date 02/20/2025), and Lot # NA4005E (expiration date 02/20/2025).
The recalled product
- Product
- Sodium Chloride Injection 9%, USP, 500 mL, Single-Dose IV Bottle, Rx Only, nephron, 503B outsourcing facility, West Columbia, SC 29172, NDC: 69374-334-50
- Manufacturer
- Nephron Sterile Compounding Center LLC
- Category
- Drug — Sterile Injectable
- Affected units
- 4,190
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 (3)
- Lot # NA4008B
- exp. date 03/03/2025 Lot # NA4005B & NA4005E
- exp. date 02/20/2025
Distribution
Distributed nationwide across the United States.
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