Recall Enforment Report D-0176-2023

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Nephron Sc Inc, originally initiated on 01-13-2023 for the product S2 Racepinephrine Inhalation Solution, USP 2.25% Bronchodilator 30x0.5 mL Sterile Unit-of-Use Vials each in a foil pouch, Manufactured By: Nephron West Columbia, SC 29172, NDC 0487-5901-99 UPC 3 04875 90199 9 The product was recalled due to short fill. The product was distributed nationwide and the recall is currently terminated.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0176-202301-13-202302-01-2023Class II925,920 vialsS2 Racepinephrine Inhalation Solution, USP 2.25% Bronchodilator 30x0.5 mL Sterile Unit-of-Use Vials each in a foil pouch, Manufactured By: Nephron West Columbia, SC 29172, NDC 0487-5901-99 UPC 3 04875 90199 9Short FillTerminated
D-0175-202301-13-202302-01-2023Class II387,000 vialsAsthmanefrin Racepinephrine Inhalation Solution Bronchodilator (racephedrine, USP 11.25), 30x0.5 mL Sterile Vials each in a foil pouch, NDC 0487-2784-01 UPC 3 04872 78401 4Short FillTerminated

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
0487-2784Asthmanefrin Racepinephrine HydrochlorideSolutionRespiratory (inhalation)Nephron Pharmaceuticals CorporationHuman Otc Drug
0487-5901S2 Racepinephrine HydrochlorideSolutionRespiratory (inhalation)Nephron Sc, Inc.Human Otc Drug