According to the report, "The batches in question tested negative for Cronobacter and other bacteria and this is an isolated situation. After a thorough investigation, we have identified the root cause, which was linked to a material from a third party. We have taken all appropriate corrective actions, including no longer sourcing this material from the supplier."
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/reckitt-recalls-two-batches-prosobee-129-oz-simply-plant-based-infant-formula-because-possible
Reckitt Recalls Two Batches of Prosobee 12.9 oz Simply Plant Based Infant Formula Because of Possible Health Risk
Summary
Company Announcement Date: February 20, 2023
FDA Publish Date: February 20, 2023
Product Type: Food & Beverages Infant Formula & Foods
Reason for Announcement: Potential Cronobacter sakazakii contamination
Company Name: Reckitt
Brand Name: Enfamil ProSobee
Product Description: Enfamil Prosobee Simply Plant-Based Infant Formula in 12.9 oz containers
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/reckitt-recalls-two-batches-prosobee-129-oz-simply-plant-based-infant-formula-because-possible
Reckitt Recalls Two Batches of Prosobee 12.9 oz Simply Plant Based Infant Formula Because of Possible Health Risk
Summary
Company Announcement Date: February 20, 2023
FDA Publish Date: February 20, 2023
Product Type: Food & Beverages Infant Formula & Foods
Reason for Announcement: Potential Cronobacter sakazakii contamination
Company Name: Reckitt
Brand Name: Enfamil ProSobee
Product Description: Enfamil Prosobee Simply Plant-Based Infant Formula in 12.9 oz containers
Company Announcement
‘The company has issued a correction to the previous announcement’.
Product tested and confirmed negative for contaminants.
No reported adverse consumer reactions to date.
Reckitt, a producer of nutrition products, announced today that, out of an abundance of caution, it has chosen to voluntarily recall two (2) select batches of ProSobee 12.9 oz. Simply Plant-Based Infant Formula due to a possibility of cross-contamination with Cronobacter sakazakii. All product distributed went through extensive testing and tested negative for the bacteria.
ProSobee Simply Plant-Based Infant Formula in 12.9 oz containers was manufactured between August 2022 and September 2022. The products were distributed through retail stores nationwide in the U.S., Guam, and Puerto Rico. The batches in question can be identified by the number on the bottom of the can. Recalled product batches are ZL2HZF and ZL2HZZ both with a UPC Code of 300871214415 and a “Use By Date” of “1 Mar 2024.” The recall involves approximately 145,000 cans.
No other ProSobee Simply Plant-Based Infant Formula batches or other Reckitt products are impacted.
No illnesses or adverse events have been reported. If parents have any questions, they should consult with their pediatrician or contact us at 1-800-479-0551 24/7 or by email at consumer.relations@rb.com
We are committed to the highest level of quality and safety and it is for this reason that we have taken this extraordinary measure. The batches in question tested negative for Cronobacter and other bacteria and this is an isolated situation. After a thorough investigation, we have identified the root cause, which was linked to a material from a third party. We have taken all appropriate corrective actions, including no longer sourcing this material from the supplier.
The health and safety of infants is our highest priority. All of our products undergo rigorous and industry leading quality tests and checks to ensure that they meet or exceed all standards set by regulatory bodies, including the World Health Organization and the U.S. Food and Drug Administration. It is for this reason that we have the highest level of confidence in the safety and quality of every infant formula we make.
What Consumers Should Do if They Purchased This Product
Consumers who purchased ProSobee Simply Plant-Based Infant Formula should check the bottom of the can to identify whether the batch number is affected. Product with batch codes ZL2HZF and ZL2HZZ both with a UPC Code of 300871214415 and a “Use By Date” of “1 Mar 2024” should be disposed of or returned to the place of purchase for a total refund. You can also contact us at 800-479-0551 or by email at consumer.relations@rb.com and we will help verify if this product was impacted.
If you have any concerns, contact your health care provider. For more information please visit us at www.enfamil.comExternal Link Disclaimer
###
About Cronobacter
Cronobacter bacteria can cause severe, life-threatening infections (sepsis) or meningitis (an inflammation of the membranes that protect the brain and spine). Symptoms of sepsis and meningitis may include poor feeding, irritability, temperature changes, jaundice (yellow skin and whites of the eyes), grunting breaths and abnormal movements. Cronobacter infection may also cause bowel damage and may spread through the blood to other parts of the body.
‘The company has issued a correction to the previous announcement’.
Product tested and confirmed negative for contaminants.
No reported adverse consumer reactions to date.
Reckitt, a producer of nutrition products, announced today that, out of an abundance of caution, it has chosen to voluntarily recall two (2) select batches of ProSobee 12.9 oz. Simply Plant-Based Infant Formula due to a possibility of cross-contamination with Cronobacter sakazakii. All product distributed went through extensive testing and tested negative for the bacteria.
ProSobee Simply Plant-Based Infant Formula in 12.9 oz containers was manufactured between August 2022 and September 2022. The products were distributed through retail stores nationwide in the U.S., Guam, and Puerto Rico. The batches in question can be identified by the number on the bottom of the can. Recalled product batches are ZL2HZF and ZL2HZZ both with a UPC Code of 300871214415 and a “Use By Date” of “1 Mar 2024.” The recall involves approximately 145,000 cans.
No other ProSobee Simply Plant-Based Infant Formula batches or other Reckitt products are impacted.
No illnesses or adverse events have been reported. If parents have any questions, they should consult with their pediatrician or contact us at 1-800-479-0551 24/7 or by email at consumer.relations@rb.com
We are committed to the highest level of quality and safety and it is for this reason that we have taken this extraordinary measure. The batches in question tested negative for Cronobacter and other bacteria and this is an isolated situation. After a thorough investigation, we have identified the root cause, which was linked to a material from a third party. We have taken all appropriate corrective actions, including no longer sourcing this material from the supplier.
The health and safety of infants is our highest priority. All of our products undergo rigorous and industry leading quality tests and checks to ensure that they meet or exceed all standards set by regulatory bodies, including the World Health Organization and the U.S. Food and Drug Administration. It is for this reason that we have the highest level of confidence in the safety and quality of every infant formula we make.
What Consumers Should Do if They Purchased This Product
Consumers who purchased ProSobee Simply Plant-Based Infant Formula should check the bottom of the can to identify whether the batch number is affected. Product with batch codes ZL2HZF and ZL2HZZ both with a UPC Code of 300871214415 and a “Use By Date” of “1 Mar 2024” should be disposed of or returned to the place of purchase for a total refund. You can also contact us at 800-479-0551 or by email at consumer.relations@rb.com and we will help verify if this product was impacted.
If you have any concerns, contact your health care provider. For more information please visit us at www.enfamil.comExternal Link Disclaimer
###
About Cronobacter
Cronobacter bacteria can cause severe, life-threatening infections (sepsis) or meningitis (an inflammation of the membranes that protect the brain and spine). Symptoms of sepsis and meningitis may include poor feeding, irritability, temperature changes, jaundice (yellow skin and whites of the eyes), grunting breaths and abnormal movements. Cronobacter infection may also cause bowel damage and may spread through the blood to other parts of the body.
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