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Recall Observatory FDA recall evidence

Food product

Similac Probiotic Tri-Blend - 0.017oz (0.50g) packaged in foil packets. 50 foil packets per carton - 3 cartons per case.

F-0328-2024

October 31, 2023

Class II

Product summary

Firm
Abbott Laboratories
Event
Event 93348
Status
Terminated
Classification
Class II
Quantity
226,650 packets (4,533 cartons)
Official record key
food-enforcement:F-0328-2024

Official wording

Reason: Marketed towards preterm infants without approval as a new drug or licensed biologic, as well as unsafe food additive

Code information: Lot No. 45002IP Product No. 67397 Best By 09/01/24

Distribution pattern: Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Marketed towards preterm infants without approval as a new drug or licensed biologic, as well as unsafe food additive