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FDA ADVISORY

Mead Johnson recalls Lactum infant formula batch on product-label mismatch


Mead Johnson Nutrition has voluntarily recalled a batch of Lactum infant formula brand from the market due to a mismatch between the label indicated on the box and the actual product content, the Food and Drug Administration (FDA) said Friday.

The company has informed the FDA of the voluntary recall of Lactum Instant Formula Powder 0-6 months 350 grams with the following specifics:

  • Batch No. PL9GDL5B
  • Manufacturing date – July 12, 2019
  • Expiration date – January 12, 2021

The product recall was “due to difference in the actual product inside the box which instead contains Lactum Infant Formula Powder 6-12 Months,” according to an FDA advisory.

“Mead Johnson Nutrition received a report from their authorized retailer that there was a discrepancy between the product marked in their storage and the actual product,” the FDA said.

The batch on recall contained Lactum Infant Formula Powder 6-12 Months, intended for infants 6 to 12 months old.

Although Mead Johnson Nutrition has not received any adverse reports related to the box-product mismatch, the company has decided to proceed with caution and voluntarily recalled the product from the market.

"Please note that this voluntary batch recall is a packaging concern and additional information about it is available on our website and in released public service advisories. The safety and quality of our products are a non-negotiable priority for us and we have taken all necessary measures to ensure retrieval of the batch,"  Mead Johnson said in a statement.

The company assured that the issue affects only the product with batch number PL9GDL5B.

"As of (September 1), we have recovered 292 pieces out of 300, or about 97%, of the affected pieces, and still closely coordinating with trade partners and retailers to retrieve the remaining products," it said.

In its advisory, the FDA warned the public against “feeding the recalled batch to your infants aged 0-6 months as this may cause dehydration and electrolyte imbalance due to the formulation being intended for infants aged 6-12 months.”

“Furthermore, there is a greater risk for Cronobacter sakazakii infection for infants under 2 months of age as the inappropriate formulation inside (Instant Infant Formula 6-12 Months), does not require verification testing and ingredient controls for Cronobacter spp,” the FDA added.

Cronobacter sakazakii is a foodborne bacterium which causes infections in newborns.

The FDA advised consumers who may have purchased the above product to contact Mead Johnson Nutrition Center hotline at (02) 841-8222 for information on how to obtain either a replacement product or full refund.

Consumers may also email the FDA at info@fda.gov.ph for any question or additional information regarding the recall.

“All Officers of the Field Regulatory Operations Office are hereby ordered to monitor the availability of the product with the specified batch number in the market and instruct the concerned establishment to return the sealed stocks to Mead Johnson Nutrition for proper disposal,” the FDA said. —VDS, GMA News