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EZ Breathe Atomizer Recall

  • Date: 2013/05/11 (Rev. 2013/10/21)
  • Nephron Pharmaceuticals Corporation
  • Synopsis : Health & Life, Co. LTD nationwide recall EZ Breathe Atomizers Model #EZ-100 after becoming aware of an increase in the number of complaints.

Main Document

Medical Device Recall News Release - Health & Life Co., LTD. Issues Nationwide Recall of EZ Breathe Atomizer, Model #EZ-100

On May 8, 2013, Health & Life, Co., LTD, initiated a nationwide recall of 242,892 EZ Breathe Atomizers, Model #EZ-100, after becoming aware of an increase in the number of complaints. The Atomizers have been determined to have the possibility of a manufacturing defect which results in a quarter-inch diameter washer becoming dislodged from the EZ Breathe Atomizer, which potentially could result in a choking hazard. This product is manufactured by Health & Life Co., LTD. in Taiwan for Nephron Pharmaceuticals Corp., who is managing the recall activities. No injuries have been reported to date.

The EZ BreatheAtomizer can be found in these three presentations:

1) Packaged in the Asthmanefrin Starter Kit, NDC 0487-2784-10. Each Asthmanefrin Starter Kit contains 10 vials of Asthmanefrin medication that are manufactured by Nephron Pharmaceuticals Corp. and one EZ Breathe Atomizer.

Affected Asthmanefrin Starter Kit Lot #'s: R2029A, R2029B, R2039A, R2042A, R2045A, and R2047A.

2) EZ Breathe Atomizers Model # 100

Affected Atomizer Serial Number Ranges:
1206034476 - 1206069065
1209069180 - 1209069202
1207003710 - 1207038299
1209069203 - 1209069460
1207046505 - 1207081124
1210000001 - 1210103680
1208027421 - 1208062155
1210104001 - 1210104044
1209000001 - 1209069179
Serial numbers can be identified on the
battery door of the atomizer.

3) Replacement Medication Cup
Affected Lot #'s: 120902, 120903 and 120904
(lot numbers are found on the medication cup packaging)

EZ Breathe Atomizers Model #100
EZ Breathe Atomizers Model #100

Recalled EZ Breathe Atomizers were manufactured from May 21, 2012 through October 29, 2012 and distributed from August 3, 2012 through April 24, 2013.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Nephron Pharmaceuticals Corp. is notifying its distributors and customers by either direct mail, email or telephone and is arranging for the return of all recalled Atomizers. Nephron Pharmaceuticals Corp. distributed EZ Breathe Atomizers contained in Asthmanefrin Starter Kits nationwide to drug wholesalers, pharmacies and individuals.

Consumers who have affected EZ Breathe Atomizers (as referenced above) should stop using, and contact the EZ Breathe Atomizer Recall Customer Care Center at 1-855-413-8920, between the hours of 8:00 am and 5:00 pm EDT, for return and replacement of their EZ Breathe Atomizer at no charge.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA:

Online at www.fda.gov/Safety/MedWatch/HowToReport/default.htm (form available to fax or mail), or call FDA 1-800-FDA-1088




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