Food, drugs, devices › Nephron Sc Inc
Drug recall: Asthmanefrin Racepinephrine Inhalation Solution Bronchodilator (racephedrine, USP 11.25), 30x0.5 mL Sterile Vials each i
FDA enforcement event 91451 is a drug recall by Nephron Sc Inc of West Columbia, SC, initiated 13 Jan 2023 and classified Class II, with 2 product records.
FDA defines Class II as 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. 59% of the 281 drug enforcement events initiated in 2023 carry the same class.
Status: Terminated, terminated 11 Oct 2024. Initiation: voluntary: firm initiated. Nephron Sc Inc has 4 enforcement events on this register, with a median of 2 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Nephron Sc Inc, West Columbia, SC.
Reason for recall
"Short Fill"
Distribution
"Nationwide within the United States including Puerto Rico. Guatamala"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0175-2023 | Asthmanefrin 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 4 | 387,000 vials | Class II | Terminated | 1 Feb 2023 |
| D-0176-2023 | 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 | 925,920 vials | Class II | Terminated | 1 Feb 2023 |
Context
Other enforcement events for Nephron Sc Inc
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 23 Feb 2023 | Sterile Water for Injection, USP, 30x5 mL Single-Dose Vials, Rx Only, Nephron 4500 12th Street Extension West Columbia, | Drug | Class II | 1 |
| 12 Jan 2023 | 0.9% Sodium Chloride Injection, USP, 100 mL Single-Dose Container bag, Rx Only, Nephron Pharmaceuticals Corporation, 450 | Drug | Class II | 2 |
| 10 Aug 2022 | Ketorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL), packaged in 2 mL single dose vials, Rx Only, Nephron Pharma | Drug | Class II | 1 |
All 4 events for Nephron Sc Inc
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Short Fill"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. 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.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide within the United States including Puerto Rico. Guatamala"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 11 Oct 2024. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.