Abbott PediaSure Harvest 1.0 Cal, For Tube Feeding. Complete nutrition blend. 8 fl oz (237mL). UPC 0 70074-67963 1.
Summary
The FDA issued a Class I for Abbott PediaSure Harvest 1.0 Cal, For Tube Feeding. Complete nutrition blend. by Lyons Magnus, Inc. Reason: Findings and potential for Cronobacter sakazakii and Clostridium botulinum..
Details
Source
Food Recall
External ID
F-1664-2022
Action Date
2022-09-07
Status
Terminated
Category
food
Product Description
Abbott PediaSure Harvest 1.0 Cal, For Tube Feeding. Complete nutrition blend. 8 fl oz (237mL). UPC 0 70074-67963 1. 24 count case UPC 00070074679624. Shake very well. Store unopened at room temperature. Once opened, reclose, refrigerate, and use within 24 hours. Manufactured for Abbott Nutrition, Abbott Laboratories, Columbus, Ohio 43219-3034.
Lot/Code Info: EXPANDED 8-10-2022 Lot Code 320184X00 / Best By Date 09/01/2022 Lot Code 330194X00 / Best By Date 10/01/2022 Lot Code 330204X00 / Best By Date 10/01/2022 Lot Code 330204X01 / Best By Date 10/01/2022 Lot Code 330214X00 / Best By Date 10/01/2022 Lot Code 350264X00 / Best By Date 12/01/2022 Lot Code 360274X00 / Best By Date 01/01/2023 Lot Code 360284X00 / Best By Date 01/01/2023 Lot Code 370014X00 / Best By Date 02/01/2023 Lot Code 370024X00 / Best By Date 02/01/2023 Lot Code 380034X00 / Best By Date 03/01/2023 Lot Code 380044X00 / Best By Date 03/01/2023 Lot Code 380054X00 / Best By Date 03/01/2023 Lot Code 380064X00 / Best By Date 03/01/2023 Lot Code 380074X00 / Best By Date 03/01/2023 Lot Code 380074X01 / Best By Date 03/01/2023 Lot Code 390084X00 / Best By Date 04/01/2023 Lot Code 390094X00 / Best By Date 04/01/2023
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-1664-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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