FDA DrugsClass II
Albuterol Sulfate Inhalation Solution, 0.5%, 25 mg/5 mL (5 mg/mL*), 30x5 mL Ster...
Published: April 22, 2026Recall ID: D-0479-2026Category: drugsCountry: US
Reason for Recall / Hazard
Labelling: Illegible label
Product Description & Identification
Albuterol Sulfate Inhalation Solution, 0.5%, 25 mg/5 mL (5 mg/mL*), 30x5 mL Sterile Unit-Dose Vials, Rx only, nephron 503B Outsourcing facility, 4600 12th Street Extension, West Columbia, SC 29172, NDC 69374-330-05.
Additional Source Details
| Field | Value |
|---|---|
| City | West Columbia |
| State | SC |
| Event id | 98596 |
| Address 1 | 4500 12th Street Ext |
| Address 2 | N/A |
| Code info | Lot AB6001, exp date 1/15/2027 |
| Postal code | 29172-3025 |
| Report date | 20260422 |
| Product type | Drugs |
| Product quantity | 146,280 vials |
| Reason for recall | Labelling: Illegible label |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260317 |
| Initial firm notification | N/A |
| Center classification date | 20260414 |
Overview
- Recalling FirmNephron SC, LLC
- StatusOngoing
- Risk LevelClass II
- DistributionNationwide within the United States