Abbott Similac Total Comfort 638g. plastic jar and 8oz. can. 6 units per case. Abbott Similac Advance Step-2 34oz. can
Summary
The FDA issued a Class I for Abbott Similac Total Comfort 638g. plastic jar and 8oz. can. 6 units per case. by Abbott Laboratories. Reason: Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facil.
Details
Source
Food Recall
External ID
F-0928-2022
Action Date
2022-03-16
Status
Ongoing
Category
food
Product Description
Abbott Similac Total Comfort 638g. plastic jar and 8oz. can. 6 units per case. Abbott Similac Advance Step-2 34oz. can. 6 cans per case. Item numbers: 6635013 6635113 6698413 Retail UPCs: 055325626602 055325626626 055325001652
Lot/Code Info: Batches: 23420SH00 32608SH00 26820K800 33725K800 37277K800 26821SH00 28089SH00 29245SH00 32607SH00 34861SH00 36124SH00
Quantity Affected: 109848 cases
Reason for Recall
Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facility where the product had been produced
Distribution
US Nationwide. Worldwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-02-17
Company
Abbott Park, IL
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 92 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 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 (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-0928-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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