EZ Breathe Medication Cup. For the delivery of liquid medications for respiratory usage.
This recall has been terminated (originally issued May 29, 2013).
- Company
- Nephron Pharmaceuticals Corp.
- Recall Initiated
- April 30, 2013
- Posted
- May 29, 2013
- Terminated
- June 28, 2016
- Recall Number
- Z-1373-2013
- Quantity
- 750 Medications Cups
- Firm Location
- Orlando, FL
- Official Source
- View on FDA website ↗
Reason for Recall
Possible dislodgement of the "Plate A", if this instance occurs, it presents a potential choking hazard.
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.
Lot / Code Info
Lots #120902, Lot # 120903 and Lot # 120904
Root Cause
Nonconforming Material/Component
Action Taken
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.