來源：FDA 發(fā)表時間：2023-03-24 10:26:34 瀏覽：次
Summary
Company Announcement Date:
March 17, 2023
FDA Publish Date:
March 17, 2023
Product Type:
Food & Beverages
Reason for Announcement:
Potential Cronobacter sakazakii contamination
Company Name:
Perrigo Company plc
Brand Name:
Gerber Good Start
Product Description:
Powdered Infant formula
Company Announcement
Dublin, Ireland – March 17, 2023 – Perrigo Company plc is issuing 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 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.
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.
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. Any consumers who purchased product with matching codes should discontinue use and dispose of the product.
Gerber? Good Start? SootheProTM 12.4 oz:
300357651Z – USE BY 04JUL2024
300457651Z – USE BY 05JUL2024
300557651Z – USE BY 06JUL2024
300557652Z – USE BY 06JUL2024
300757651Z – USE BY 08JUL2024
300857651Z – USE BY 09JUL2024
301057651Z – USE BY 11JUL2024
301057652Z – USE BY 11JUL2024
301157651Z – USE BY 12JUL2024
Gerber? Good Start? SootheProTM 30.6 oz:
301357652Z – USE BY 14JUL2024
301457652Z – USE BY 15JUL2024
301557651Z – USE BY 16JUL2024
Gerber Good? Start? SootheProTM 19.4 oz:
301557652Z – USE BY 16JUL2024I
Consumers can request refunds for impacted products and find more information about Gerber? Good Start? by contacting the Gerber Parent Resource Center on behalf of Perrigo at 1-800-777-7690 anytime 24/7. Consumers with any health-related questions should contact their healthcare provider.
This recall is being conducted in consultation with the U.S. Food and Drug Administration (FDA).
For over 130 years, Perrigo has been committed to meeting the needs of consumers—and the quality and safety of our products is our highest priority. We have numerous regulatory approved procedures throughout the manufacturing process to control for Cronobacter sakazakii. Every batch of infant formula is tested to make certain it meets stringent nutritional, safety, quality, and regulatory requirements. As part of our rigorous protocols to protect the safety of families and infants, we are proactively taking this action.
About Perrigo
Perrigo Company plc is a leading provider of Consumer Self-Care Products and over-the-counter (OTC) health and wellness solutions that enhance individual well-being by empowering consumers to proactively prevent or treat conditions that can be self-managed. Visit Perrigo online at www.perrigo.com.
On November 1, 2022, Perrigo acquired Nestlé's Gateway Eau Claire, Wisconsin, plant, along with the U.S. and Canadian rights to the Good Start? infant formula brand. Perrigo operates the Good Start? infant formula brand in the United States and Canada while Nestlé operates the Good Start? infant formula brand for Women Infants and Children (WIC) contracts.
Media Contact
Tim Schramm, (908) 370-4771, E-mail: tschramm@coynepr.com
Company Contact Information
Consumers:
Gerber Parent Resource Center on behalf of Perrigo
?1-800-777-7690
Media:
Tim Schramm
?908-370-4771
?tschramm@coynepr.com
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