|TOPIC: Limited Quantity of Gerber Good Start SootheProTM Powdered Infant Formula by Perrigo: Recall – Due to Potential Cronobacter sakazakii Contamination|
AUDIENCE: Consumer, Patient, Health Professional, Pediatric, Gastroenterology
ISSUE: Perrigo Company is recalling 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 is being recalled out of an abundance of caution due to the potential presence of Cronobacter sakazakii.
Importantly, no distributed product has tested positive for the presence of this bacteria, no adverse events have been reported and no other products manufactured at this facility or any other of Perrigo’s facilities are affected by this recall.
This product is sold at retailers across the U.S. Consumers who purchased the product after March 5, 2023 should look for the following Lot Codes and “use by” dates, which can be found on the bottom of the package. No other lot codes are impacted by this recall.
For more information about this recall, click on “Read Recall” below.
BACKGROUND: 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.
RECOMMENDATION: Any consumers who purchased product with matching codes should discontinue use and dispose of the product.
|Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:|
– Complete and submit the report online.
– Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.