FDA Drug recall D-66462-001
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,…
- FDA Drug
- Class II
- terminated
- Published 2013-10-30
On 2013-10-30 the FDA classified a Class II recall of 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,… by Nephron Pharmaceuticals, citing lack of Assurance of Sterility: Nephron Pharmaceuticals Corporation conducted a routine periodic aseptic process simulation and discovered bacterial growth in a number of media fi….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-66462-001 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-10-02 |
| Published | 2013-10-30 |
| 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 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
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.
Identifiers
| ndc | 0487-9501-25 |
|---|---|
| ndc | 0487-9501-03 |
| ndc | 0487-9501-60 |
| ndc | 0487-9501-01 |
| code_info | Lots #: A3A33A, A3A33B, A3A34A, A3A35A. A3A36A, A3A37A, A3A38A, Exp 06/15; A3A40A, A3A41A, A3A42A, Exp 07/15 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
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FDA Drug · Class II · 2019-10-30 · Nephron Pharmaceuticals
All Nephron Pharmaceuticals recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-66462-001%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.