FDA Drug recall D-1446-2012
Albuterol Sulfate Inhalation Solution, 0.083%, 2.5 mg/3 mL Sterile Unit-Dose Vials, 60-count (60 x 3 mL Sterile Unit-Dose Vials) per carton…
- FDA Drug
- Class II
- terminated
- Published 2012-08-15
On 2012-08-15 the FDA classified a Class II recall of Albuterol Sulfate Inhalation Solution, 0.083%, 2.5 mg/3 mL Sterile Unit-Dose Vials, 60-count (60 x 3 mL Sterile Unit-Dose Vials) per carton… by Nephron Pharmaceuticals, citing lack of Assurance of Sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1446-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2011-06-22 |
| Published | 2012-08-15 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Nephron Pharmaceuticals |
| Distribution | US |
Product
Albuterol Sulfate Inhalation Solution, 0.083%, 2.5 mg/3 mL Sterile Unit-Dose Vials, 60-count (60 x 3 mL Sterile Unit-Dose Vials) per carton, Rx only, Manufactured by: nephron pharmaceuticals corporation, Orlando, FL 32811, NDC 0487-9501-60.
Reason
Lack of Assurance of Sterility
Identifiers
| ndc | 0487-9501-25 |
|---|---|
| ndc | 0487-9501-03 |
| ndc | 0487-9501-60 |
| ndc | 0487-9501-01 |
| code_info | Lot #: A0654A, Exp 07/12; A0A62A, Exp 10/12 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1446-2012%22
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