FDA Drug recall D-0010-2016
Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg Inhalation Solution, packaged in 30x3 mL Sterile Unit-Dose Vials, a) 30 count (NDC 04…
- FDA Drug
- Class II
- terminated
- Published 2015-10-21
On 2015-10-21 the FDA classified a Class II recall of Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg Inhalation Solution, packaged in 30x3 mL Sterile Unit-Dose Vials, a) 30 count (NDC 04… by Nephron Pharmaceuticals, citing lack of Assurance of Sterility; potential exposure to non-sterile lubricant during the filling process.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0010-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-08-21 |
| Published | 2015-10-21 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Nephron Pharmaceuticals |
| Distribution | US |
Product
Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg Inhalation Solution, packaged in 30x3 mL Sterile Unit-Dose Vials, a) 30 count (NDC 0487-0201-03) and b) 60 count (NDC 0487-0201-60) vials per carton, Rx only, Nephron Pharmaceutical Corporation, Orlando, FL
Reason
Lack of Assurance of Sterility; potential exposure to non-sterile lubricant during the filling process
Identifiers
| ndc | 0487-0201-01 |
|---|---|
| ndc | 0487-0201-02 |
| ndc | 0487-0201-03 |
| ndc | 0487-0201-60 |
| code_info | a) Lot D4E20A, exp 3/2016 and b) Lot D4C21A, exp 3/2016 |
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-0010-2016%22
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