Similac Probiotic Tri-Blend - 0.017oz (0.50g) packaged in foil packets. 50 foil packets per carton - 3 cartons per case.
Summary
The FDA issued a Class II for Similac Probiotic Tri-Blend - 0.017oz (0.50g) packaged in foil packets. 50 foil by Abbott Laboratories. Reason: Marketed towards preterm infants without approval as a new drug or licensed biologic, as well as unsafe food additive.
Details
Source
Food Recall
External ID
F-0328-2024
Action Date
2023-11-15
Status
Terminated
Category
food
Product Description
Similac Probiotic Tri-Blend - 0.017oz (0.50g) packaged in foil packets. 50 foil packets per carton - 3 cartons per case.
Lot/Code Info: Lot No. 45002IP Product No. 67397 Best By 09/01/24
Quantity Affected: 226,650 packets (4,533 cartons)
Reason for Recall
Marketed towards preterm infants without approval as a new drug or licensed biologic, as well as unsafe food additive
Distribution
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
Type: Voluntary: Firm initiated
Recall Initiated: 2023-10-31
Company
Columbus, OH
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 106 food recalls issued in the same week, part of 204 food-related FDA actions this month.
Abbott Laboratories has 101 FDA actions in our database, including 86 recalls and 15 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Abbott Laboratories) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Abbott Laboratories have FDA actions?
Abbott Laboratories has 101 FDA actions in our database, including 86 recalls and 15 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "F-0328-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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