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Terminated

Urea Base Agar, Acumedia PN 7226 Urea Agar Base is used with agar for the differentiation of microorganisms on the basis of urease production

FDA Recall Z-2221-2017 · Posted None

Recalling FirmAcumedia Manufacturers, Inc.
Recall StatusTerminated
Product CodeJSI
Date Initiated2016-09-25
Date Terminated2017-06-02
Product Quantity28 units

Reason for Recall

Storage temperature listed on the label was incorrect. Label stated 2-30C. Actual storage temperature is 2-8C.

Firm Action

Neogen Corporation sent a Product Notification dated September 25, 2016, to all affected consignees via email. The recall notification included a description of the reason for the recall, affected product, and information for the correction to product. Consignees were informed that an internal corrective action has been initiated and actions have been taken and implemented to prevent this situation from occurring again. The label has been corrected and existing inventory has been relabeled. For questions regarding this recall call 800-234-5333, ext 2362.

Root Cause

Error in labeling

Distribution Pattern

Worldwide Distribution - US to AZ; Internationally to ECUADOR; CANADA; UK; BRAZIL

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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