Recall Z-0283-2019
Acumedia Manufacturers, Inc. · initiated August 2, 2018
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
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.
Codes / lots: Lot 110321B
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.
FDA-determined cause: Error in labeling
Action taken
Product Notification letters dated 8/2/18 were sent to customers.
Details
- Recall number
- Z-0283-2019
- Initiated
- August 2, 2018
- Terminated
- December 18, 2020
- Product code
- JSI – Culture Media, Selective And Differential
- Quantity
- 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.
- Recalling firm
- Acumedia Manufacturers, Inc., Lansing, MI