Abbott voluntarily recalls batch of Similac Tummicare One Infant Formula —FDA

Abbott Laboratories has voluntarily recalled a batch of infant formula from the market due to inconsistencies in the label instructions and the size of the accompanying scoop for preparing the product, the Food and Drug Administration (FDA) said.

In an advisory, the FDA said that Abbot informed the agency of the voluntary recall of Similac Tummicare One Infant Formula 820 grams with the following specifics:

• Batch No. 03518QU

• Manufacturing date – March 2019

• Expiration date – March 2022

“Abbott Laboratories Inc. received an inquiry from a customer regarding the inconsistency between the scoop size and preparation instructions on the label of the product,” the FDA noted.

“The affected batch contained a smaller red preparation scoop compared with the white preparation scoop that is shown on the label instructions,” it said.

Although Abbott has not received any adverse reports for this incident, the company has decided to proceed with caution and voluntarily recalled the product from the market, according to FDA Philippines.

“This recall applies only to the product with batch no. 03518QU and no other Abbott Laboratories products are affected by this recall,” the FDA said.

Despite the recall, the FDA said the product is safe to consume.

“However, if the red scoop is used to prepare the formula according to the label instructions and provided to an infant as sole source of nutrition, it would not provide sufficient nutrition to support normal growth,” it said.

The FDA advised consumers who may have purchased the product to contact Abbott Laboratories hotline at (02) 995-1555 (Manila) or 1800-10-995-1555 (Province) or email familyties.ph@abbott.com for information on how to obtain either a replacement product or full refund.

The public may also email the FDA at info@fda.gov.phfor any question or additional information regarding the recall.

“All Officers of the Field Regulatory Operations Office (FROO) 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 Abbott Laboratories for proper disposal,” the FDA said. —VDS, GMA News