Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Sabouraud Dextrose Agar w /Lecithin and Tween 20 Acumedia PN 91081 Product Usage: Used for the isolation of fungi from surfaces sanitized with quaternary ammonium compounds

FDA Recall Z-2212-2017 · Posted 2017-06-01

Recalling FirmAcumedia Manufacturers, Inc.
Recall StatusTerminated
Product CodeJSG
Date Initiated2016-08-08
Date Terminated2017-06-02
Product Quantity10 units

Reason for Recall

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

Firm Action

On 8/8/2016 and 10/6/2016, 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.

Root Cause

Error in labeling

Distribution Pattern

US in the state of IL

Official Source

View FDA Recall →

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

↑