Luitpold Recalls Concentrated Sodium Chloride Injection Due to Particulate Matter
Luitpold Pharmaceuticals is recalling concentrated sodium chloride injection vials because visual particles were found in retention samples.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically involves a situation that may cause temporary or medically reversible adverse health consequences. The hazard is the presence of particulate matter, which is a quality control issue rather than a high-risk pathogen or structural defect.
Plain-English summary
Luitpold Pharmaceuticals, Inc. is recalling specific lots of Concentrated Sodium Chloride Injection, USP, 23.4%. The affected products are 30 mL single-dose vials and 100 mL pharmacy bulk packages. The recall covers 2,078,800 vials of the 30 mL size and 167,100 vials of the 100 mL size.
The recall was initiated because visual particles were observed in retention samples during inspection. The products were distributed nationwide, in Puerto Rico, and in Abu Dhabi. Specific lot numbers for both the 30 mL and 100 mL packages are listed in the recall documentation.
Healthcare providers and pharmacies should stop using the affected lots and contact Luitpold Pharmaceuticals for further instructions. Patients should consult their healthcare provider if they have questions regarding the use of this medication.
The recalled product
- Product
- CONCENTRATED SODIUM CHLORIDE INJECTION, USP, 23.4% a) 30 mL SINGLE DOSE VIAL, (NDC 0517-2930-25), b) 100 mL PHARMACY BULK PACKAGE (NDC 0517-2900-25), Rx Only, AMERICAN REGENT, INC. SHIRLEY, NY 11967.
- Manufacturer
- Luitpold Pharmaceuticals, Inc.
- Category
- Drug — Injectable Solution
- Hazard
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 (20)
- 30 mL Lots: 9198
- 9252
- 9299
- 9305
- 9402
- 9423
- 9432
- 9553
- 9595
- 9646
- 9681
- 9737
- 9797
- 9831
- 0051
- 0095
- 0362
- 100 mL Lots: 9225
- 9492
- 9711
Distribution
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