FDA Drug recall D-0388-2016
Asthmanefrin Racepinephrine Inhalation Solution Bronchodilator, Starter Kit (Racepinephrine 11.25 mg) 10 individual foil wrapped vials with…
- FDA Drug
- Class II
- terminated
- Published 2015-12-09
On 2015-12-09 the FDA classified a Class II recall of Asthmanefrin Racepinephrine Inhalation Solution Bronchodilator, Starter Kit (Racepinephrine 11.25 mg) 10 individual foil wrapped vials with… by Nephron Pharmaceuticals, citing discoloration.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0388-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-08-21 |
| Published | 2015-12-09 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Nephron Pharmaceuticals |
| Distribution | US |
Product
Asthmanefrin Racepinephrine Inhalation Solution Bronchodilator, Starter Kit (Racepinephrine 11.25 mg) 10 individual foil wrapped vials with 1 EZ Breathe Atomizer per carton, Manufactured By: nephron pharmaceuticals corporation, Orlando, FL --- NDC 0487-2784-10
Reason
Discoloration
Identifiers
| code_info | Lots R4027A (Exp 10/31/2015), R4036A (Exp 12/31/2015) |
|---|
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-0388-2016%22
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