Z-0283-2019Class III

Palcam Agar Base, Acumedia, PN 7669, Product Usage - Dehydrated culture media used with supplements as a...

Name: Z-0283-2019 Palcam Agar Base, Acumedia, PN 7669, Product Usage - Dehydrated culture media used with supplements as a...
Creator: Acumedia Manufacturers, Inc.
Published: 2018-08-02
License: https://open.fda.gov/license/

Neogen Culture Media / initiated 2018-08-02 / Terminated / root cause: labeling and UDI

FDA source

Acumedia Manufacturers, Inc. began a recall of Palcam Agar Base, Acumedia, PN 7669, Product Usage - Dehydrated culture media used with supplements as a selective and differential medium for the detection... on 2018-08-02. FDA classified it as Class III and gives the reason as "Expiration date on the label is incorrect. Correct expiration date was November 30, 2020 and label on distributed product listed the expiration date as November 30, 2021". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0283-2019
Classification: Class III
Status: Terminated
Initiated: 2018-08-02
Posted: 2018-10-26
Terminated: 2020-12-18
Recalling firm: Neogen Culture Media
Product: Palcam Agar Base, Acumedia, PN 7669, Product Usage - Dehydrated culture media used with supplements as a selective and differential medium for the detection and isolation of Listeria monocytogenes from foods and environmental samples in a laboratory setting. Not intended for use in the diagnosis of disease or other conditions in humans.
Product code: JSI Culture Media, Selective And Differential
Reason for recall: Expiration date on the label is incorrect. Correct expiration date was November 30, 2020 and label on distributed product listed the expiration date as November 30, 2021.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Product Notification letters dated 8/2/18 were sent to customers.
Quantity in commerce: 22 bottles
Distribution: Worldwide distribution and US nationwide in the states of CA, GA, MN, OR, RI, TX, and WY. Countries of Canada, Mexico, Scotland, and Uruguay.
Product codes and lots: Lot 110321B

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0283-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0283-2019	Class III	Terminated	Voluntary: Firm initiated	2018-11-07	2018-10-26

Product code JSI

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)