Recall Review: Associated Wholesale Grocers, Inc.

Associated Wholesale Grocers, Inc. is Releasing this Notice Due to Recalled Infant Formula Being Distributed to its Nashville Division Retailers after the Initial Recall Notice was Published

FDA Published Date – May 14, 2023

Company Announcement

On March 17, 2023, the Perrigo Company issued a voluntary recall of certain lots of Gerber® Good Start® SootheProTM Powdered Infant Formula in the U.S., that were manufactured at the Company’s Gateway Eau Claire, Wisconsin manufacturing facility from January 02, 2023 to January 18, 2023. This product was recalled out of an abundance of caution due to the potential presence of Cronobacter sakazakii. Associated Wholesale Grocers, Inc. (AWG) is releasing this additional notice due to one of the recalled products being distributed to its Nashville Division retailers after the initial recall notice was published.

Cronobacter sakazakii is a bacteria commonly found in the environment. In most people, it causes no symptoms but in some, particularly premature infants, infants under 2 months of age or infants with weakened immune systems, fever, poor feeding, excessive crying or low energy as well as other serious symptoms can occur.

For more on this recall, click here


What is Cronobacter sakazakii? Where is it found, and why should we be concerned?  What are some sources of Cronobacter sakazakii in a manufacturing facility?  How can you prevent it from entering your production stream?

Cronobacter sakazakii, formerly Enterobacter sakaakii, is a pathogenic organism commonly found in the environment and can live for extended periods in low moisture areas, like the ground of manufacturing facilities, preparation areas, and utensils, if not cleaned properly.

Due to the organism’s viability in low-moisture environments, it can live in low-moisture foods such as infant formula but has been found in many other fresh and frozen foods and food ingredients.

Cronobacter sakazakii has been found to live in powdered infant formula for over two years.

As identified by the FDA, it does not cause symptoms in most people but can infect people with a compromised immune system and infants less than two months of age.

Prevention methods include the following;

  • Employee awareness and training on this organism.
  • Proper Good Manufacturing Practices, GMPs, including handwashing.
  • Incoming ingredient review (COA) and random 3rd party testing to assure ingredient quality.
  • FDA Environmental Monitoring – 21 CFR 117.165.
  • Robust Master Sanitation Schedule and Program (MSS).
  • Separating employees that handle “raw” and “processed” foods and components.
  • Ensure your production system’s airflow is sufficient and meets the organization’s standards (positive pressure in finished product zones, etc.)
  • Monitor system utilities – air, water, steam, compressed air.

As always, following any findings, there should be a review process (Post-Mortem, After Action Report (AAR), Root Cause Analysis (RCA), etc. with communications going out to the organization to prevent a reoccurrence.

Together we can all do our part to be advocates for prevention and drive out recalls worldwide!

In The Midst Of A Recall - Food Manufacturing - Recall Prevention - Walk through - Business bookFor more information on how to prevent recalls, check out my book “In the Midst of a Recall” for real-world measures you can take now to prepare with in-depth Case Studies. Available now




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