Nutricia KetcoCal 4:1 LQ Unflavored in 237ml (8fl oz) packaged in tetra prisma paper aseptic carton - 3 cartons per box
Summary
The FDA issued a Class II for Nutricia KetcoCal 4:1 LQ Unflavored in 237ml (8fl oz) packaged in tetra prisma p by Nutricia North America. Reason: Incorrect product in packaging.
Details
Source
Food Recall
External ID
F-0406-2024
Action Date
2023-11-15
Status
Terminated
Category
food
Product Description
Nutricia KetcoCal 4:1 LQ Unflavored in 237ml (8fl oz) packaged in tetra prisma paper aseptic carton - 3 cartons per box *Sample Kits*
Lot/Code Info: Expiration: DEC 10 2023 Batch/Lot 2023.12.10
Quantity Affected: 283 kits
Reason for Recall
Incorrect product in packaging
Distribution
247 kits shipped within US (Alabama, California, Colorado, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, New Hampshire, New Jersey, New Mexico, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Texas, Virginia, Washington, Wisconsin) 36 kits shipped within Canada (Ontario, Quebec, Prince Edward, British Columbia, Alberta)
Type: Voluntary: Firm initiated
Recall Initiated: 2023-10-20
Company
Rockville, MD
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.
Nutricia North America has 2 FDA actions in our database, including 2 recalls.
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 (Nutricia North America) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Nutricia North America have FDA actions?
Nutricia North America has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "F-0406-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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