Doc-U-Dose Prescription Management System, Item #8-PKIT. The product is distributed in cartons. There are 1,000 sets of

FDA device recall Z-0045-2007 · posted 2006-10-19 · Terminated

Recall details

Recalling firm

Eatonform Inc

Reason for recall

Certain lots of packet components of the firm's Doc-U-Dose Prescription Management System are separating from the paper along the sealed seam at the bottom of the packets causing the medications inside the separated compartments to fall completely out of the packet, or to become mixed into the wrong compartment of the packaging.

Action taken

The firm issued recall notifications which were sent via UPS overnight delivery to all of their pharmacy customers on 8/2/2006, 8/4/2006, and 8/11/2006. In their recall notifications, the firm requested that the pharmacy customers: 1) cease using and distributing all Doc-U-Dose packets identified with the recalled lot numbers; 2) segregate and secure all Doc-U-Dose packets identified with the suspect lot numbers on-hand; 3) inform the firm as to whether or not they have any of the suspect product which they would be returning and the quantity of product to be returned; 4) return all packets to Eatonform at the recalling firms expense; and 5) notify their subaccount customers and ask that they cease using the device until such time as the problem is corrected.

Root cause

Other

Status

Terminated

Product code

NXQ

Quantity affected

approximately 913 cartons

Distribution

Nationwide

Date initiated

2006-08-02

Date posted

2006-10-19

Date terminated

2012-05-21

Location

Dayton, OH