Sodium Chloride Injection Recalled for Manufacturing Control Deviations
Nephron Pharmaceuticals is recalling 378 bags of 0.9% Sodium Chloride Injection nationwide due to manufacturing deviations that could create product carryover.
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 classified this as Class II. The product is an intravenous injection where any potential contamination due to manufacturing deviations represents a risk-of-harm situation. Although no illnesses have been reported and the contamination is potential rather than confirmed, the IV route of administration elevates the concern beyond precautionary measures.
Plain-English summary
Nephron Pharmaceuticals Corporation is recalling 378 bags of 0.9% Sodium Chloride Injection, USP (100 mL single-dose containers) distributed nationwide. The recall is due to Current Good Manufacturing Practice (CGMP) deviations identified during manufacturing that could result in trace amounts of product carryover.
The affected product is Lot 271043, with an expiration date of March 2023, NDC 0487-4301-10. This is a prescription intravenous injection.
Patients and healthcare providers in possession of affected units from this lot should not use the product. They should contact Nephron Pharmaceuticals or their healthcare provider for information about alternatives.
The recalled product
- Product
- SODIUM CHLORIDE (SODIUM CHLORIDE)
- Brand
- SODIUM CHLORIDE
- Manufacturer
- Nephron Sc Inc
- Category
- Drug — Intravenous Injection
- Affected units
- 378
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: 271043
- Exp. 03/2023
UPCs (6)
- 0304874301257
- 0000000000000
- 0304874301509
- 0304874301059
- 0304874301103
- 304874301103
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Nephron Sc Inc under a single FDA (Drugs) 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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