Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
CONCENTRATED SODIUM CHLORIDE INJECTION Recalled by Luitpold Pharmaceuticals, Inc. Due to Presence of Particulate Matter: In the course of...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Luitpold Pharmaceuticals, Inc. directly.
Affected Products
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.
Quantity: 30 mL: 2,078,800 vials; 100 mL: 167,100 vials
Why Was This Recalled?
Presence of Particulate Matter: In the course of inspecting retention samples visual particles were observed.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Luitpold Pharmaceuticals, Inc.
Luitpold Pharmaceuticals, Inc. has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report