1. On May 3, 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; however, to mitigate any future risk, sale, distribution or use of any remaining product should be discontinued immediately. The EZ Breathe Atomizer is packaged in the, NDC#: 0487-2784-10. 2. Please immediately remove, discontinue use or cease distribution of all Asthmanefrin Starter Kits impacted by the EZ Breathe Atomizer device recall. The table below indicates the impacted s: PRODUCT DESCRIPTION IMPACTED LOT NUMBER(S) R2029A R2029B R2039A R2042A R2045A R2047A Each contains 10 vials of Asthmanefrin medication and a single EZ Breathe Atomizer unit. The carton is depicted below: The lot numbers may be identified on Panel B of the carton. 3. Please return all recalled product: Nephron Pharmaceuticals Corporation 78 Spruce St. Murray, KY 42071
The completed Return Response Form may be delivered via fed-ex, e-mail or fax. Please indicate the intended method of delivery below. DIRECT DELIVERY E-MAIL FAX Nephron Pharmaceuticals Corporation Customerservice@ezbreatheatomizer.com Nephron Pharmaceuticals Corporation 78 Spruce St. 407-849-0929 Murray, KY 42071 Please note, this form must be completed in its entirety and returned to Nephron Pharmaceuticals Corporation. Completion and return of the Return Response Form is required even if there is no current inventory of the recalled product to be returned. 4. Please check all applicable boxes that describe your business. Wholesaler/Distributor Retail Pharmacy Retailer Hospital Pharmacies Hospital/Medical Hospital Pharmacy Other: 5. Please indicate the quantity of product being returned for each impacted lot of the Asthmanefrin Starter Kit : NDC NUMBER PRODUCT DESCRIPTION LOT NUMBER QUANTITY RETURNED (# of starter kits) 0487-2784-10 R2029A 0487-2784-10 R2029B 0487-2784-10 R2039A 0487-2784-10 R2042A 0487-2784-10 R2045A 0487-2784-10 R2047A 6. Please check all appropriate boxes. I have read and understand the recall instructions provided. I have inspected my current stock and quarantined inventory identified within the impacted serial ranges. I have records of which consumers received impacted product and notified consumers identified as receiving impacted product. Method of Notification: Date of Notification: I do not have records of which consumers received impacted product.
7. Please indicate the contact information of the individual responsible for completing this Return Response Form. First and Last Name (Print): Date: Title/Position: Company/Business Name: Address: Phone Number: Fax Number: I certify that, to the best of my knowledge, the information provided in the completed Return Response Form is true and correct. Signature: Date: