Z-0189-2007

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

Name: Z-0189-2007 Doc-U-Dose Prescription Management System, Item 8-PKIT. The product is packaged and distributed in cartons...
Creator: Eatonform Inc
Published: 2006-09-28
License: https://open.fda.gov/license/

Eatonform Inc / initiated 2006-09-28 / Terminated

FDA source

Eatonform Inc began a recall of Doc-U-Dose Prescription Management System, Item 8-PKIT. The product is packaged and distributed in cartons. Each carton contains 1,000 sets of four packets or... on 2006-09-28. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0189-2007
Status: Terminated
Initiated: 2006-09-28
Posted: 2006-11-16
Terminated: 2012-05-21
Recalling firm: Eatonform Inc
Product: Doc-U-Dose Prescription Management System, Item 8-PKIT. The product is packaged and distributed in cartons. Each carton contains 1,000 sets of four packets or 4,000 individual packets per carton.
Product code: NQX System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
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.
FDA root cause: Other
Action: 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.
Quantity in commerce: 24 cartons [24,000 sets of four packets each]
Distribution: Nationwide.
Product codes and lots: Carton numbers: 16 through 39 were subject to recall.

Product code NQX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)