Health & Life, Co., LTD, is recalling 242,892 EZ Breathe atomizers, Model #EZ-100.
The atomizers have the possibility of a manufacturing defect that results in a quarter-inch diameter washer becoming dislodged, which potentially could result in a choking hazard. No injuries have been reported to date.
The EZ Breathe Atomizer 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)
|The recalled EZ Breathe Atomizers were manufactured from May 21, 2012, through October 29, 2012, and distributed from August 3, 2012, through April 24, 2013 .|
Nephron Pharmaceuticals is notifying its distributors and customers by either direct mail, email or telephone and is arranging for the return of all recalled Atomizers. The company distributed EZ Breathe Atomizers contained in Asthmanefrin Starter Kits nationwide to drug wholesalers, pharmacies and individuals.
Consumers who have the affected products should stop using them and contact the EZ Breathe Atomizer Recall Customer Care Center at 1-855-413-8920, between 8:00 am and 5:00 pm EDT, for return and replacement at no charge.