CLASS II Drug recall · Reported 1 Feb 2023 · FDA Enforcement Report
S2 Racepinephrine Inhalation Solution recalled by Nephron Sc
Nephron Sc is recalling S2 Racepinephrine Inhalation Solution, USP 2.25% Bronchodilator . Sterile Unit-of-Use, distributed nationwide in the US. The recall was initiated on 13 Jan 2023 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0176-2023
- FDA event ID
- 91451
- Recalling firm
- Nephron Sc, West Columbia, SC
- Brand
- S2
- Manufacturer
- Nephron Pharmaceuticals Corporation
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 Jan 2023
- FDA classified
- 23 Jan 2023
- Reported
- 1 Feb 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Allergy Medication
Timeline
| 13 Jan 2023 | Recall initiated by company | |
| 23 Jan 2023 | Classified by FDA | +10 days |
| 1 Feb 2023 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Short Fill
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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
Where it was distributed
Nationwide within the United States including Puerto Rico. Guatamala
Questions about this recall
Why was it recalled?
Short Fill
Which lots are affected?
Lot #: 126461, 126431 Exp. 04/30/2023
Where was it sold?
Nationwide within the United States including Puerto Rico. Guatamala
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 91451| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Asthmanefrin Racepinephrine Inhalation Solution recalled by Nephron Sc | Nephron Sc | Packaging Defects | Nationwide |
More recalls from Nephron Sc
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Albuterol Sulfate Inhalation Solution, 0.5%, 25 mg recalled | Nephron SC | Other | Nationwide |
| Drug | CLASS II | Sterile Water for Injection, USP, mL Single-Dose Vials recalledSterile Water | Nephron Sc | Manufacturing (CGMP) Deviations | SC |
| Drug | CLASS II | Asthmanefrin Racepinephrine Inhalation Solution recalled by Nephron Sc | Nephron Sc | Packaging Defects | Nationwide |
| Drug | CLASS II | Sterile Water for Injection recalled by Nephron ScSterile Water | Nephron Sc | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | 0.9% Sodium Chloride Injection, USP Single-Dose Container recalledSodium Chloride | Nephron Sc | Manufacturing (CGMP) Deviations | Nationwide |
Other Racepinephrine recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Racepinephrine Inhalation Solution recalled by Mckesson Medical-SurgicalS2 | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |