Nephron Recalls Sodium Chloride Inhalation Solution Due to Sterility Concerns
Nephron Pharmaceuticals is recalling 13,692 cartons of Sodium Chloride Inhalation Solution due to a failure in the internal dye ingress test, which raises concerns about the sterility of the vials.
The agency’s classification
FDA (Devices): 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: The recall is classified as FDA Class II, and the hazard involves a risk of harm (loss of sterility) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Nephron Pharmaceuticals Corp. is recalling 13,692 cartons of Sodium Chloride Inhalation Solution, USP 7%, 60 x 4 mL Sterile Unit-Dose Vials (NDC 0487-9007-60). The recall is limited to Lot Number N4753A with an expiration date of 11/16. The product is a prescription-only sterile, preservation-free solution used for respiratory therapy to induce sputum production.
The recall was initiated due to a lack of assurance of sterility. Specifically, an internal dye ingress test failed to assure the integrity of the vial, which could potentially compromise the sterile nature of the product. The affected units were distributed worldwide, including to numerous US states and Canada.
Healthcare providers and patients should discontinue use of the affected lot and contact Nephron Pharmaceuticals or their supplier for further instructions or replacement.
The recalled product
- Product
- Sodium Chloride Inhalation Solution, USP 7%, 60 x 4 mL Sterile Unit-Dose Vials, Rx Only, NDC 0487-9007-60. A vial contains sterile, preservation-free, clear, colorless, aqueous solution as labeled for induction of sputum production where specimen collection is indicated. For…
- Manufacturer
- Nephron Pharmaceuticals Corp.
- Affected units
- 13,692
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 (2)
- Lot Number N4753A
- Exp 11/16
Distribution
Part of a larger recall action
This product is one of 2 recalled by Nephron Pharmaceuticals Corp. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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