Albuterol Sulfate Inhalation Solution — Class II drug recall D-1446-2012
Terminated recall by Nephron Pharmaceuticals Corp., reported 2012-08-15, distributed nationwide. Lack of Assurance of Sterility
| Recall number | D-1446-2012 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nephron Pharmaceuticals Corp., Orlando, FL, United States |
| Recall initiated | 2011-06-22 |
| Classified | 2012-08-09 |
| Reported by FDA | 2012-08-15 |
| Terminated | 2012-11-15 |
| Distributed | Nationwide (US) |
| Quantity | 56,028 cartons |
| Reason classes | sterility |
| NDC | 00487-9501, 00487-9501-01, 00487-9501-03, 00487-9501-25, 00487-9501-60 |
| Lot numbers | 07/12, 10/12, A0654A, A0A62A |
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 for recall
Lack of Assurance of Sterility
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1446-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.