Recall Z-1373-2013 ยท CCQ Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
Nephron Pharmaceuticals Corp.
EZ Breathe Medication Cup. For the delivery of liquid medications for respiratory usage.
| Date | May 29, 2013 (initiated Apr 30, 2013) |
| Status | Terminated |
| Reason | Possible dislodgement of the "Plate A", if this instance occurs, it presents a potential choking hazard. |
| Root cause | Nonconforming Material/Component |
| Action | The firm, Nephron Pharmaceuticals Corporation, notified its consignees on April 30, 2013, and May 3, 2013, of the problem via a recall notice and a Press Release, respectively. The firm directed consignees to discontinue use of any EZ Breathe atomizer units contained in the Asthmanefrin Starter Kits with the affected lot numbers and also those that were sold individually. Customers were directed to return all affected product. |
| Quantity | 750 Medications Cups |
| Distribution | Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of AL, AZ, CA, CO, CT, FL, IL, IN, IO, GA, KS, KY, LA, MD, MN, MS, MO, NK, NV, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN , TX, VT, VA, WA, and WV, and the countries of Guatemala, Poland, Panama, and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.