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Terminated

EZ Breathe Atomizer Model # EZ-100. For the delivery of liquid medications for respiratory usage.

FDA Recall Z-1371-2013 · Posted 2013-05-29

Recalling FirmNephron Pharmaceuticals Corp.
Recall StatusTerminated
Product CodeCCQ
Date Initiated2013-04-30
Date Terminated2016-06-28
Product Quantity604 each

Reason for Recall

Possible dislodgement of the "Plate A", if this instance occurs, it presents a potential choking hazard.

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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