FDA Medical Device Recalls (openFDA)
Nephron Pharmaceuticals Corp.: EZ Breathe Medication Cup. For the delivery of liquid medications for respiratory usage.
- Recall number
- Z-1373-2013
- Recalling firm
- Nephron Pharmaceuticals Corp.
- Product
- EZ Breathe Medication Cup. For the delivery of liquid medications for respiratory usage.
- Status
- Terminated
- Initiated
- 2013-04-30
- Posted
- 2013-05-29
- Terminated
- 2016-06-28
- 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.
- Lot, serial or model codes
- Lots #120902, Lot # 120903 and Lot # 120904
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- CCQ
- Firm FEI
- 3010892830
- Firm city
- Orlando
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28