kate farms Pediatric Peptide 1.5 Cal/mL, Vanilla, Sole-Source Nutrition Formula. 250 mL (8.45 fl oz) UPC 8 51823-0068
Summary
The FDA issued a Class I for kate farms Pediatric Peptide 1.5 Cal/mL, Vanilla, Sole-Source Nutrition Formula by Lyons Magnus, Inc. Reason: Findings and potential for Cronobacter sakazakii and Clostridium botulinum..
Details
Source
Food Recall
External ID
F-1672-2022
Action Date
2022-09-07
Status
Terminated
Category
food
Product Description
kate farms Pediatric Peptide 1.5 Cal/mL, Vanilla, Sole-Source Nutrition Formula. 250 mL (8.45 fl oz) UPC 8 51823-00687 4. 12 count case UPC 00851823006201. Shake Well. A ready-to-use oral and tube feeding formula with enzymatically hydrolyzed organic pea protein. Made for Kate Farms, Inc., 101 Innovation Place, Santa Barbara, CA 93708
Lot/Code Info: EXPANDED 8-10-2022 Lot Code 0031 / Best By Date 10/27/2022 Lot Code 1031 / Best By Date 10/28/2022 Lot Code 3221 / Best By Date 08/11/2022 Lot Code 3531 / Best By Date 12/19/2022 Lot Code 4221 / Best By Date 08/12/2022 Lot Code 4531 / Best By Date 12/20/2022 Lot Code 6131 / Best By Date 11/12/2022 Lot Code 6721 / Best By Date 10/03/2022 Lot Code 7131 / Best By Date 11/13/2022
Quantity Affected: 53,818,025 total units
Reason for Recall
Findings and potential for Cronobacter sakazakii and Clostridium botulinum.
Distribution
Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2022-07-22
Company
Fresno, CA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 111 food recalls issued in the same week, part of 204 food-related FDA actions this month.
Lyons Magnus, Inc has 78 FDA actions in our database, including 78 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
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 (Lyons Magnus, Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Lyons Magnus, Inc have FDA actions?
Lyons Magnus, Inc has 78 FDA actions in our database, including 78 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "F-1672-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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