Albuterol Sulfate Inhalation Solution — Class II drug recall D-66462-001
Terminated recall by Nephron Pharmaceuticals Corp., reported 2013-10-30, distributed nationwide. Lack of Assurance of Sterility: Nephron Pharmaceuticals Corporation conducted a routine periodic aseptic proce
| Recall number | D-66462-001 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nephron Pharmaceuticals Corp., Orlando, FL, United States |
| Recall initiated | 2013-10-02 |
| Classified | 2013-10-18 |
| Reported by FDA | 2013-10-30 |
| Terminated | 2015-08-21 |
| Distributed | Nationwide (US) |
| Quantity | 689,568 cartons |
| Reason classes | microbial contamination, sterility |
| NDC | 00487-9501, 00487-9501-01, 00487-9501-03, 00487-9501-25, 00487-9501-60 |
| Lot numbers | 06/15, 07/15, A3A33A, A3A33B, A3A34A, A3A35A, A3A36A, A3A37A, A3A38A, A3A40A, A3A41A, A3A42A |
Product
Albuterol Sulfate Inhalation Solution, 0.083% 2.5 mg/3 mL for Oral Inhalation Only, Rx Only, 25 x 3 mL Sterile Unit-Dose Vials per carton, Manufactured By: Nephron Pharmaceuticals Corporation, Orlando, FL 32811, NDC 0487-9501-25
Reason for recall
Lack of Assurance of Sterility: Nephron Pharmaceuticals Corporation conducted a routine periodic aseptic process simulation and discovered bacterial growth in a number of media fill vials, exceeding the allowable limit.
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-66462-001. 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.