Multi event Drug Recall Enforcement Report Class II voluntary initiated by Nephron Pharmaceuticals Corp., originally initiated on 08-21-2015 for the 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 The product was recalled due to discoloration. The product was distributed nationwide and the recall is currently terminated.
Recall Enforcement Reports
| Recall Number |
Recall Initiation Date |
Report Date |
Recall Classification |
Quantity |
Product Description |
Recall Reason |
Status |
| D-0388-2016 | 08-21-2015 | 12-09-2015 | Class II | 47,754 cartons | 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 | Discoloration | Terminated |
| D-0389-2016 | 08-21-2015 | 12-09-2015 | Class II | 32,490 cartons | Asthmanefrin Racepinephrine Inhalation Solution Bronchodilator Refills (Racepinephrine USP 11.25 mg), 30 individual foil wrapped vials per carton, Manufactured By: nephron pharmaceuticals corporation, Orlando, FL --- NDC 0487-2784-01 | Discoloration | Terminated |
Recalled Products
| NDC |
Proprietary Name |
Non-Proprietary Name |
Dosage Form |
Route Name |
Company Name |
Product Type |
| 0487-2784 | Asthmanefrin | Racepinephrine Hydrochloride | Solution | Respiratory (inhalation) | Nephron Pharmaceuticals Corporation | Human Otc Drug |
