Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2214-2017Class III

Beef Extract Powder, Acumedia PN 7228

Neogen Culture Media / initiated 2015-09-11 / Terminated / root cause: labeling and UDI

Acumedia Manufacturers, Inc. began a recall of Beef Extract Powder, Acumedia PN 7228 Product Usage: Beef Extract Powder is prepared and standardized for use in microbiological culture media, where it is... on . FDA classified it as Class III and gives the reason as "Incorrect expiration date on label. Correct expiration date was March 25, 2019. Product was labeled with expiration date of March 28,2019". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number
Z-2214-2017
Classification
Class III
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Neogen Culture Media
Product
Beef Extract Powder, Acumedia PN 7228 Product Usage: Beef Extract Powder is prepared and standardized for use in microbiological culture media, where it is generally used to replace infusion of meat. Culture media containing Beef Extract Powder are recommended for use in bacteriological examination of water, milk, and other materials, where uniform composition of media is important. Beef Extract Powder is relied upon for biochemical studies, particularly fermentation reactions because of its independence from ferment-able substances. Several media containing Beef Extract Powder are recommended in standard methods for multiple application.
Product code
JSK Supplement, Culture Media
Reason for recall
Incorrect expiration date on label. Correct expiration date was March 25, 2019. Product was labeled with expiration date of March 28,2019.
Root cause tag
labeling and UDI
FDA root cause
Error in labeling
Action
On 9/11/2015, notifications were sent to the affected consignees via e-mail. The recall notification included a description of the reason for the recall, affected product, and information for the correction to product.
Quantity in commerce
16 units
Distribution
Worldwide - US Nationwide in the state IL and the country of COLOMBIA
Product codes and lots
PN 7228, Lot 107984A

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-2214-2017
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2214-2017Class IIITerminatedVoluntary: Firm initiated