Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0045-2007

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

Eatonform Inc / initiated 2006-08-02 / Terminated / root cause: packaging

Eatonform Inc began a recall of Doc-U-Dose Prescription Management System, Item #8-PKIT. The product is distributed in cartons. There are 1,000 sets of four (4) packets, or 4,000 individual... on . The reason FDA records is "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...". As of , the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number
Z-0045-2007
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Eatonform Inc
Product
Doc-U-Dose Prescription Management System, Item #8-PKIT. The product is distributed in cartons. There are 1,000 sets of four (4) packets, or 4,000 individual packets per carton. Each set is one day's worth of four packets, which are labeled, ''morning,'' ''noon,'' ''evening,'' and ''bedtime.''
Product code
NXQ Reminder, Medication
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.
Root cause tag
packaging
FDA root cause
Other
Action
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.
Quantity in commerce
approximately 913 cartons
Distribution
Nationwide
Product codes and lots
Four (4) lot codes are subject to recall: 312733, 312734, 313767, and 313768. This accounts for all of the Doc-U-Dose packets distributed by the firm since May 13, 2006.