Doc-U-Dose Prescription Management System, Item 8-PKIT. The product is packaged and distributed in cartons. Each carton

FDA device recall Z-0189-2007 · posted 2006-11-16 · Terminated

Recall details

Recalling firm

Eatonform Inc

Reason for recall

The poly film may separate along the sealed seams of the packets of the Doc-U-Dose Prescription Management System causing the medications to unintentionally fall out of the packets prior to delivery to patient/consumers.

Action taken

The firm issued recall notifications which were sent via UPS overnight delivery to all of their pharmacy customers on 9/28/2006. In their recall notification, the firm requests that the customers: 1) Cease using and distributing all Doc-U-Dose packets identified with the recalled carton numbers [instructions are provided as to how to identify the carton number]; 2) Segregate and secure all Doc-U-Dose packets identified with the suspect carton numbers [16 - 39 inclusive] or any packets from open cartons bearing those numbers; 3) Complete the attached Recall Verification Form which requests information concerning whether or not the customer(s) have any of the suspect product which they will be returning and the quantity of product to be returned; and provide the signature, title, and date of completion of the form by the individual responsible for carrying out the recall action [According to the recalling firm's instructions, the Verification Form is to be returned to Eatonform by fax or E-mail , no later than 3 business days following the receipt of the recall notification. Lastly, a toll-free no. is provided and the customer(s) is asked to call the firm's Packet Return Center and obtain instructions for returning any of the packets found on-hand [at the recalling firm's expense] and to return all packets to Eatonform as instructed.

Root cause

Other

Status

Terminated

Product code

NQX

Quantity affected

24 cartons [24,000 sets of four packets each]

Distribution

Nationwide.

Date initiated

2006-09-28

Date posted

2006-11-16

Date terminated

2012-05-21

Location

Dayton, OH