Nephron Recalls Sodium Chloride Inhalation Solution Due to Sterility Concerns
Nephron Pharmaceuticals is recalling 11,208 cartons of Sodium Chloride Inhalation Solution because internal dye tests failed to confirm vial integrity.
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: The recall is classified as FDA Class II. The hazard involves a lack of assurance of sterility in a medical device, which poses a risk of harm, but the source text does not report any specific illnesses or injuries.
Plain-English summary
Nephron Pharmaceuticals Corp. is recalling 11,208 cartons of Sodium Chloride Inhalation Solution, USP 3%, 60 x 4 mL Sterile Unit-Dose Vials (NDC 0487-9003-60). The recall is limited to Lot Number N4745A with an expiration date of 09/16.
The recall was initiated due to a lack of assurance of sterility. Internal dye ingress tests failed to assure the integrity of the vials, raising concerns that the sterile solution may have been compromised. The product is a prescription-only medication used in conjunction with a nebulizer for respiratory therapy to induce sputum production.
The affected units were distributed worldwide, including to numerous US states and Canada. Healthcare providers and patients should stop using the recalled product and contact Nephron Pharmaceuticals for further instructions or a replacement.
The recalled product
- Product
- Sodium Chloride Inhalation Solution, USP 3%, 60 x 4 mL Sterile Unit-Dose Vials per carton, Rx Only, NDC 0487-9003-60. A vial contains sterile, preservation-free, clear, colorless, aqueous solution as labeled for induction of sputum production where specimen collection is indica
- Manufacturer
- Nephron Pharmaceuticals Corp.
- Hazard
- Affected units
- 11,208
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 N4745A
- Exp 09/16
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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