STA Neooplastine CI 10 의 리콜

Recall

50125

Class 2

Z-0501-2009

2008-10-20

2008-12-18

Terminated

United States

2010-06-24

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74780

Internal investigation has determined the potential lack of homogeneity between product vials.

Product Recall Notice letters were sent to all customers on October 20, 2008 vis US mail. The letter stated the reason for the notice, the corrective action, and replacement process. Customers are to confirm that they received the Recall Notice by completing the attached "Product Recall Response Form" and return by fax to the Regulatory Affairs Department at 973-867-6028 or 973-695-0095. The firm is prepared to immediately implement the following corrective action: 1) perform QC testing in accordance to directions from the package insert on each vial and destroy vial and replace inventory if determined product was unsatisfactory OR 2) return inventory for replacement with new lots of inventory. If customers have any questions or need any technical assistance, they are to call the DSI Hotline at 1-800-222-2624, option 1.